Trial Outcomes & Findings for MAGE-A4ᶜ¹º³²T for Multi-Tumor (NCT NCT03132922)
NCT ID: NCT03132922
Last Updated: 2026-05-07
Results Overview
An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
71 participants
Primary outcome timeframe
From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).
Results posted on
2026-05-07
Participant Flow
This was an open-label Phase 1 dose escalation study of afamitresgene autoleucel in HLA-A\*02 positive participants with MAGE-A4 expressing unresectable locally advanced or metastatic cancer of the following types: urothelial, melanoma, head and neck, ovarian, NSCLC, esophageal (squamous and adenocarcinoma), gastric, synovial sarcoma, or MRCLS. This study had a substudy component that investigated the safety and tolerability of afamitresgene autoleucel in combination with low dose radiation.
The main study could enroll up to 18 participants in the dose escalation phase (data cut off 01Sep2020). Following the dose escalation phase, the study was expanded to enroll up to approximately 30 participants at the selected dose range (inclusive of those treated during dose escalation at that dose range) across all the eligible tumor types to better characterize and assess overall safety. The sub study planned to enroll up to 10 participants (data cut off 13Jan2022).
Participant milestones
| Measure |
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 (±20%) transduced cells
|
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 3 + Expansion
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
32
|
4
|
|
Overall Study
Received Afamitresgene Autoleucel
|
3
|
3
|
32
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
29
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 (±20%) transduced cells
|
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 3 + Expansion
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
|
|---|---|---|---|---|
|
Overall Study
Ongoing in Interventional phase at data cut-off (1Sep2020)
|
0
|
0
|
3
|
0
|
Baseline Characteristics
MAGE-A4ᶜ¹º³²T for Multi-Tumor
Baseline characteristics by cohort
| Measure |
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 (±20%) transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
Substudy: Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion (1.2-10x10\^9 transduced cells).
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
24 Participants
n=114 Participants
|
3 Participants
n=318 Participants
|
31 Participants
n=280 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
1 Participants
n=318 Participants
|
11 Participants
n=280 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
10 Participants
n=114 Participants
|
3 Participants
n=318 Participants
|
19 Participants
n=280 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
22 Participants
n=114 Participants
|
1 Participants
n=318 Participants
|
23 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
2 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
31 Participants
n=114 Participants
|
4 Participants
n=318 Participants
|
40 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
3 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=318 Participants
|
1 Participants
n=280 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
29 Participants
n=114 Participants
|
3 Participants
n=318 Participants
|
38 Participants
n=280 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=318 Participants
|
0 Participants
n=280 Participants
|
PRIMARY outcome
Timeframe: From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years).Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
An AE was defined as any untoward medical occurrence in a clinical study participant who received a pharmaceutical product, regardless of causality. An AE was , therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AEs (including SAEs) are presented.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Adverse Events (AE) Including Serious Adverse Events (SAE)
|
4 Participants
|
3 Participants
|
3 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: From afamitresgene autoleucel infusion up to 18 months post-infusionPopulation: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for persistence
Peak persistence of afamitresgene autoleucel cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Peak Persistence
|
185,532.5800 DNA copies/microgram
Standard Deviation 116322.7494
|
10766.23 DNA copies/microgram
Standard Deviation 12504.705
|
88900.26 DNA copies/microgram
Standard Deviation 53873.432
|
165035.89 DNA copies/microgram
Standard Deviation 99806.129
|
PRIMARY outcome
Timeframe: From afamitresgene autoleucel infusion to 3 months post-infusionPopulation: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel and had a post-infusion sample tested for VSV-G by qPCR (RCL)
The presence of RCL was assessed by quantitative polymerase chain reaction (qPCR) targeting a segment of the vesicular stomatitis virus glycoprotein (VSV-G) coding sequence.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Replication Competent Lentivirus (RCL)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)Population: mITT Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
ORR, defined as the proportion of participants with Best Overall Response (BOR) of confirmed completed response (CR) or partial response (PR) among participants with measurable disease at Baseline. The ORR was based on the assessment of response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by local radiologist. Participants with unknown or missing response were treated as non-responders.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From afamitresgene autoleucel infusion until disease progression/recurrence (up to 3.2 years)Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
BOR was defined as the best response recorded from the date of T-cell infusion until disease progression. Response categories from best to worst were, confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), and not evaluable (NE) (per RECIST v1.1)
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Best Overall Response (BOR)
Not evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Best Overall Response (BOR)
Partial response
|
1 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
|
Best Overall Response (BOR)
Stable disease
|
3 Participants
|
2 Participants
|
3 Participants
|
14 Participants
|
|
Best Overall Response (BOR)
Progressive disease (PD)
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
|
Best Overall Response (BOR)
Complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From afamitresgene autoleucel infusion until first documented confirmed CR or PRPopulation: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel achieving CR or PR.
TTR was defined as the interval between the date of the first T-cell infusion and the earliest date of the first documented confirmed CR or confirmed PR.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=1 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=9 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Time to Response (TTR)
|
NA Weeks
Only one participant in this arm achieved a response. With a single observation event, a median time to response and confidence interval cannot be estimated.
|
—
|
—
|
6.4 Weeks
Interval 6.143 to 24.143
|
SECONDARY outcome
Timeframe: From initial confirmed response (DR or PR) until PD or censored date. is defined as all participants who had not experienced the event of interest (i.e. ongoing, event free) at the time of the data cut off (used for the analysis).Population: No patients in Groups 1 and 2 achieved objective response.
DoR was measured from the first CR/PR (whichever was first recorded) until the first date of progressive disease.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=1 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=9 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Duration of Response (DoR)
|
NA Weeks
Upper confidence interval bounds were not estimable in some arms due to censoring
|
—
|
—
|
25.6 Weeks
Interval 12.286 to
Upper confidence interval bounds were not estimable in some arms due to censoring
|
SECONDARY outcome
Timeframe: From date of afamitresgene autoleucel infusion to first date of radiological PD or censored datePopulation: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
DoSD was defined as the time from the date of T-cell infusion to the first date of the radiological PD. This analysis of DoSD only applied to participants with BOR as confirmed CR, confirmed PR, or confirmed SD.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=2 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=23 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Duration of Stable Disease (DoSD)
|
25.143 Weeks
Interval 13.143 to
Upper confidence interval bounds were not estimable in some arms due to censoring
|
12.3 Weeks
Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable.
|
12.1 Weeks
Confidence intervals could not be estimated for some arms due to a limited number of events and censoring; therefore, only median duration of stable disease is reported where applicable.
|
20.4 Weeks
Interval 12.286 to 37.857
|
SECONDARY outcome
Timeframe: From afamitresgene autoleucel infusion until first documented PD or death due to any cause, whichever comes first, or censored date.Population: Participants who received afamitresgene autoleucel or LDR/ afamitresgene autoleucel
PFS was defined as the time from the date of the first T-cell infusion to the first date of the radiological PD or death date (due to any reason), whichever event was earlier.
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
19.143 Weeks
Interval 11.571 to
Upper confidence interval bounds were not estimable in some arms due to censoring
|
8.9 Weeks
Interval 5.571 to 12.286
|
12.1 Weeks
Interval 10.857 to 12.143
|
12.4 Weeks
Interval 10.0 to 20.429
|
SECONDARY outcome
Timeframe: From afamitresgene autoleucel infusion until death due to any reason or censored date From afamitresgene autoleucel infusion until death due to any reason or censored dateOS was defined as the time from the date of afamitresgene autoleucel infusion to the date of death (due to any reason).
Outcome measures
| Measure |
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 Participants
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
Afamitresgene Autoleucel, Group 1
n=3 Participants
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 Participants
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel Group 3 + Expansion
n=32 Participants
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
NA Weeks
Interval 11.571 to
Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms.
|
19.8 Weeks
Interval 18.857 to 20.714
|
NA Weeks
Median overall survival was not reached in some arms at the time of data cutoff due to ongoing survival; therefore, median OS and associated confidence intervals are not reported for those arms.
|
42.9 Weeks
Interval 25.429 to
Upper confidence interval bounds were not estimable in some arms due to censoring
|
Adverse Events
Afamitresgene Autoleucel, Group 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Afamitresgene Autoleucel, Group 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Afamitresgene Autoleucel, Group 3 + Expansion
Serious events: 23 serious events
Other events: 32 other events
Deaths: 15 deaths
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Afamitresgene Autoleucel, Group 1
n=3 participants at risk
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 participants at risk
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 3 + Expansion
n=32 participants at risk
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 participants at risk
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
|---|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
8/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Endocarditis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Rash pustular
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
15.6%
5/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Encephalopathy
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Asparate aminotransferase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Psychiatric disorders
Mental status change
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
Other adverse events
| Measure |
Afamitresgene Autoleucel, Group 1
n=3 participants at risk
Participants who received afamitresgene autoleucel 0.1x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 2
n=3 participants at risk
Participants who received afamitresgene autoleucel 0.5-1.2x10\^9 transduced cells
|
Afamitresgene Autoleucel, Group 3 + Expansion
n=32 participants at risk
Participants who received afamitresgene autoleucel 1.2-10x10\^9 transduced cells
|
Low Dose Radiation (LDR) in Combination With Afamitresgene Autoleucel
n=4 participants at risk
Participants who received LDR in combination with lymphodepletion chemotherapy followed by the afamitresgene autoleucel infusion.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
96.9%
31/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
4/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
White blood cell count decreased
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
87.5%
28/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
4/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
84.4%
27/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
4/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
56.2%
18/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
8/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
21.9%
7/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
59.4%
19/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
46.9%
15/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
37.5%
12/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Fatigue
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
59.4%
19/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
56.2%
18/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
75.0%
3/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Chills
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
8/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Malaise
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
34.4%
11/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
40.6%
13/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
28.1%
9/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
18.8%
6/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Troponin T increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
71.9%
23/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
75.0%
3/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
28.1%
9/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
37.5%
12/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
75.0%
3/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
18.8%
6/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
100.0%
3/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
21.9%
7/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
18.8%
6/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
15.6%
5/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
21.9%
7/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
18.8%
6/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
21.9%
7/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
50.0%
2/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
8/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
15.6%
5/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Endocrine disorders
Adrenal Insuffieiency
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Abdominal Pain
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
66.7%
2/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
21.9%
7/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
40.6%
13/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
62.5%
20/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
75.0%
3/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
15.6%
5/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
12.5%
4/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
8/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Weight decreased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Electocardiogram QT prolonged
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Investigations
Troponin increased
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Chest discomfort
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Face oedema
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Neutopenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Reproductive system and breast disorders
Nasal congestion
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
9.4%
3/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
6.2%
2/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Nervous system disorders
Restless leg syndrome
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
General disorders
Swelling face
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Psychiatric disorders
Mental Status Changes
|
33.3%
1/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
3.1%
1/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/3 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
0.00%
0/32 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
25.0%
1/4 • From the start of lymphodepleting chemotherapy until end of interventional phase (up to 3.2 years post-Infusion).From the start of LDR until data cut off (up to 1.7 years post-radiation).
SAEs were collected
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60