Trial Outcomes & Findings for AFPᶜ³³²T in Advanced HCC (NCT NCT03132792)
NCT ID: NCT03132792
Last Updated: 2026-06-17
Results Overview
Number of participants experiencing at least one dose-limiting toxicity (DLT) following administration of autologous genetically modified AFPᶜ³³²T cells, assessed during the protocol-defined DLT evaluation period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
The DLT observation period was from the time of chemotherapy until 30 days following the infusion of AFPc332T cells for each participant in all groups.
Results posted on
2026-06-17
Participant Flow
39 participants were enrolled and 21 received T-Cell infusion
Participant milestones
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
12
|
1
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
12
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
Baseline characteristics by cohort
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Age, Continuous
|
39.0 years
n=9 Participants
|
55.0 years
n=27 Participants
|
66.0 years
n=267 Participants
|
60.0 years
n=265 Participants
|
59.0 years
n=568 Participants
|
59.0 years
n=22 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
15 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
10 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
18 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
20 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Number of prior lines of systemic therapy
|
6.5 Lines of therapy
n=9 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
2.0 Lines of therapy
n=27 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
2.0 Lines of therapy
n=267 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
2.0 Lines of therapy
n=265 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
10.0 Lines of therapy
n=568 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
2.0 Lines of therapy
n=22 Participants • All participants who received at least one T-cell infusion (modified Intent-to-Treat \[mITT\] population; N=21)
|
PRIMARY outcome
Timeframe: The DLT observation period was from the time of chemotherapy until 30 days following the infusion of AFPc332T cells for each participant in all groups.Population: 21 participants received lymphodepletion and T-cell infusion
Number of participants experiencing at least one dose-limiting toxicity (DLT) following administration of autologous genetically modified AFPᶜ³³²T cells, assessed during the protocol-defined DLT evaluation period.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Incidence of Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first lymphodepleting chemotherapy through end of safety follow-up. Assessed at Days 9, 11, Weeks 2, 3, 4, 8, 12, 16, 24, then every 3 months until progression or withdrawal, up to approximately 4 years (data cut-off: 08 November 2022).Population: The analysis population included all participants who received at least one dose of study treatment (safety population).
Number of participants experiencing at least one treatment-emergent adverse event (TEAE) following administration of lymphodepleting chemotherapy and autologous genetically modified AFPᶜ³³²T cells.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
2 Participants
|
3 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first lymphodepleting chemotherapy through end of safety follow-up. Assessed at Days 9, 11, Weeks 2, 3, 4, 8, 12, 16, 24, then every 3 months until progression or withdrawal, up to approximately 4 years (data cut-off: 08 November 2022).Population: The analysis population included all participants who received at least one dose of study treatment (safety population).
Number of participants experiencing at least one serious adverse event (SAE) following administration of lymphodepleting chemotherapy and autologous genetically modified AFPᶜ³³²T cells
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first T-cell infusion; tumour assessments at Baseline, Weeks 4, 8, 16, 24, then every 3 months until disease progression or withdrawal, up to approximately 2 years (data cut-off: 08 November 2022).Population: 21 participants received lymphodepletion and T-cell infusion
Overall Response Rate (ORR) defined as the proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of diameters of target lesions. Response confirmation required a repeat assessment no less than 4 weeks after the criteria for response were first met.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of first confirmed CR or PR until disease progression or death due to any cause, assessed at Weeks 4, 8, 16, 24 and every 3 months thereafter, up to approximately 2 years (data cut-off: 08 November 2022).Population: Participants who achieved a confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 following T-cell infusion (mITT population). Two of 21 participants achieved a confirmed response and are included in this analysis.
Duration of response (DoR) was measured from the date of first documented confirmed Complete Response (CR) or Partial Response (PR) per RECIST v1.1 until the date of first documented disease progression or death due to any cause. Only participants achieving a confirmed CR or PR were included in this analysis.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Interval Between Date of First Documented Evidence of CR or PR Until First Documented Disease Progression or Death Due to Any Cause
|
—
|
—
|
32.3 Weeks
Interval 32.3 to 32.3
|
8.9 Weeks
Interval 8.9 to 8.9
|
—
|
SECONDARY outcome
Timeframe: From date of first documented SD until disease progression or death due to any cause, assessed at Weeks 4, 8, 16, 24 and every 3 months thereafter, up to approximately 2 years (data cut-off: 08 November 2022).Population: Participants who achieved Stable Disease (SD) per RECIST v1.1 following T-cell infusion (mITT population). Thirteen of 21 participants achieved SD and are included in this analysis.
Duration of stable disease (DoSD) was measured from the date of first documented Stable Disease (SD) per RECIST v1.1 until the date of first documented disease progression or death due to any cause. Only participants achieving SD were included in this analysis.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=7 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Interval Between the Date of First Documented Evidence of SD Until First Documented Disease Progression or Death Due to Any Cause
|
11.2 Weeks
Interval 6.7 to 15.7
|
16.4 Weeks
Interval 8.1 to 25.0
|
32.3 Weeks
Interval 32.3 to 32.3
|
25.7 Weeks
Interval 8.1 to 73.0
|
—
|
SECONDARY outcome
Timeframe: From date of first T-cell infusion until disease progression or death due to any cause, assessed at Weeks 4, 8, 16, 24 and every 3 months thereafter, up to approximately 2 years (data cut-off: 08 November 2022).Population: All participants who received at least one T-cell infusion (mITT population, N=21). Progression-free survival was assessed from the date of first T-cell infusion. Participants without a documented progression or death were censored at the date of last known tumour assessment.
Progression-free survival (PFS) was measured from the date of first T-cell infusion until the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurred first. Participants without a PFS event were censored at the date of last tumour assessment.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Interval Between the Date of First T Cell Infusion and the Earliest Date of Disease Progression or Death Due to Any Cause
|
11.2 Weeks
Interval 6.7 to 15.7
|
16.4 Weeks
Interval 8.1 to 25.0
|
4.3 Weeks
Interval 4.1 to 32.3
|
8.6 Weeks
Interval 2.3 to 73.0
|
4.3 Weeks
Interval 4.3 to 4.3
|
SECONDARY outcome
Timeframe: From date of first T-cell infusion until death due to any cause, assessed every 3 months until disease progression and every 6 months thereafter during long-term follow-up, up to approximately 4 years (data cut-off: 08 November 2022).Population: All participants who received at least one T-cell infusion (mITT population, N=21). Eight of 21 participants were alive and censored at the data cut-off of 08 November 2022.
Overall survival (OS) was measured from the date of first T-cell infusion until the date of death due to any cause. Participants who had not died at the data cut-off were censored at the date last known to be alive.
Outcome measures
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 Participants
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 Participants
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 Participants
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Interval Between the Date of First T-Cell Infusion and Date of Death Due to Any Cause
|
NA Weeks
Interval 23.1 to 196.7
Median OS was not reached in this arm at data cut-off; one of two participants was censored alive at 196.7 weeks.
|
52.9 Weeks
Interval 38.9 to 69.7
|
44.0 Weeks
Interval 22.4 to 129.3
|
42.6 Weeks
Interval 8.4 to 88.1
|
NA Weeks
Interval 5.3 to 5.3
Single participant in this arm was censored alive at 5.3 weeks at data cut-off; median OS is not calculable from a single censored observation.
|
Adverse Events
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 7 deaths
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 participants at risk
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 participants at risk
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 participants at risk
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 participants at risk
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 participants at risk
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary obstruction
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Face oedema
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Infusion-related reaction
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
Other adverse events
| Measure |
Group 1 HCC Escalation (1x10^8 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=2 participants at risk
1x10\^8 (range: 0.8x10\^8-1.2x10\^8) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 2 HCC Escalation (1x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 participants at risk
1x10\^9 (range: 0.5x10\^9-1.2x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (500mg/m2/day) and fludarabine for 3 days (20mg/m2/day)
|
Group 3 HCC Escalation (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=3 participants at risk
5x10\^9 (range: 1.2x10\^9-6x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 3 HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=12 participants at risk
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
Group 4 Non-HCC Expansion (5x10^9 Autologous Genetically Modified AFPᶜ³³²T Cells)
n=1 participants at risk
5x10\^9 (range: 1.2x10\^9-10x10\^9) autologous genetically modified AFPᶜ³³²T cells administered following lymphodepletion using cyclophosphamide for 3 days (600mg/m2/day) and fludarabine for 4 days (30mg/m2/day)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
91.7%
11/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
66.7%
2/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
75.0%
9/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
41.7%
5/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
41.7%
5/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
58.3%
7/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
50.0%
6/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
66.7%
2/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
66.7%
2/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Fatigue
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
91.7%
11/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
3/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
91.7%
11/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
4/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Chills
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
25.0%
3/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
100.0%
2/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
100.0%
1/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
33.3%
1/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
8.3%
1/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/3 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
16.7%
2/12 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
0.00%
0/1 • From first lymphodepleting chemotherapy through end of safety follow-up, assessed for up to approximately 4 years (data cut-off: 08 November 2022).
Adverse events were defined per ClinicalTrials.gov definitions. Treatment-emergent adverse events were events occurring or worsening on or after first administration of study treatment through follow-up. Events were coded using MedDRA and graded per CTCAE. Analyses used the safety population (all participants receiving ≥1 dose). No differences in definitions were identified.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place