Trial Outcomes & Findings for Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (NCT NCT05714345)
NCT ID: NCT05714345
Last Updated: 2026-03-02
Results Overview
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death.
TERMINATED
PHASE2
2 participants
Up to 60 months
2026-03-02
Participant Flow
The study enrolled participants from the United States and Europe. The informed consent date of the first participant was 01 November 2023, and the informed consent date of the last participant was 04 December 2023. The study was terminated prior to completion for business reasons, not due to safety or efficacy concerns.
Participant milestones
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Baseline characteristics by cohort
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
NA Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: Intent-to-Treat (ITT) Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed.
To assess the clinical efficacy of ALLO-647 (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by PFS and assessed by Independent Review Committee (IRC) in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma). In this study, PFS is defined as the time from randomization to disease progression, or relapse per the Lugano classification criteria (Cheson et al, 2014) as assessed by IRC or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed.
To assess the clinical efficacy of ALLO-647 as measured by ORR and assessed by Independent Review Committee (IRC) between treatment arms. ORR is defined as best overall response (Complete Response and Partial Response, assessed using the Lugano classification criteria 2014; Cheson , et al, 2014) by IRC at any time up through commencement of new anti-cancer therapy or withdrawal of consent.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed.
To assess clinical efficacy of ALLO-647 with FC (in a lymphodepletion regimen before ALLO-501A) compared to FC alone as measured by Event-Free Survival (EFS) and assessed by Independent Review Committee (IRC) in subjects with R/R LBCL. EFS is defined as the time from randomization to disease progression or relapse per the Lugano classification criteria 2014 as assessed by IRC, new anti-cancer therapy, or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: ITT Analysis Set: All randomized participants. Data does not exist as assessment of efficacy per Independent Review Committee was not performed.
To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by Independent Review Committee (IRC) between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse (per IRC) or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 60 months, study completion, or death, whichever occurs earlier. Specifically, OS was followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.Population: ITT Analysis Set: All randomized participants.
To characterize the efficacy of ALLO-647 as measured by OS, defined as the time from randomization to death.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC
|
4.50 Months
Interval 4.5 to 4.5
|
10.09 Months
Interval 10.09 to 10.09
|
SECONDARY outcome
Timeframe: Neither participant was a responder, therefore DOR was not followed. EFS and PFS were followed from first dose of study treatment until disease progression, subsequent anticancer therapy, or death. EFS and PFS were followed for 0.99 to 1.84 months.Population: ITT Analysis Set: All randomized participants. Duration of Response data is not applicable since there are no responders per investigator assessment.
To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Duration of Response (DOR), Event-Free Survival (EFS), Progression-Free Survival (PFS), assessed by investigator assessments between treatment arms. DOR is defined as time from the first observed response to disease progression or relapse per investigator assessment, or death. EFS is defined as the time from randomization to disease progression or relapse per investigator assessment per the Lugano classification criteria, new anti-cancer therapy, or death. PFS is defined as time from the randomization to progression or relapse per investigator assessment per the Lugano classification criteria, or death.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
Progression-Free Survival
|
0.99 Months
Interval 0.99 to 0.99
|
1.84 Months
Interval 1.84 to 1.84
|
|
Duration of Response, Event-Free Survival and Progression-Free Survival of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
Event-Free Survival
|
0.99 Months
Interval 0.99 to 0.99
|
1.84 Months
Interval 1.84 to 1.84
|
SECONDARY outcome
Timeframe: Overall Response Rate was followed until disease progression or subsequent anticancer therapy, whichever occurred earlier. Specifically, ORR was followed for 0.99 to 1.84 months for each participant in the FCA and FC arm, respectively.Population: ITT Analysis Set: All randomized participants.
To characterize the efficacy of ALLO-647 as measured by response rate per investigator, Overall Response Rate (ORR), and assessed by investigator assessments between treatment arms. ORR in FCA vs FC alone per investigator assessment at any time up through commencement of new anti-cancer therapy or withdrawal of consent.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study treatment to study discontinuation, death, withdrawal of consent, or date of initiation of another anticancer therapy, whichever occurs first, for a maximum of 9 months. Only Day 28 lymphocyte counts are available for both participants.Population: Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of FCA/FC or ALLO-501A. Only Day 28 lymphocyte counts are available for both participants.
To characterize the depth and duration of lymphodepletion with and without ALLO-647, as assessed by lymphocyte count.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC
|
300 cells/cubic millimeter
Interval 300.0 to 300.0
|
417 cells/cubic millimeter
Interval 417.0 to 417.0
|
SECONDARY outcome
Timeframe: Up to 60 months, study completion, or death, whichever occurs earlier. TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.Population: Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of ALLO-647 or ALLO-501A.
To evaluate the overall safety profile of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 60 months, study completion, or death, whichever occurs earlier. Related TEAEs were followed for 4.5 and 10.09 months for each participant in the FCA and FC arm, respectively.Population: Safety-Analysis Set: All randomized participants who received at least one (partial or complete) dose of ALLO-647 or ALLO-501A.
To evaluate the overall safety profile of ALLO-501A following lymphodepletion.
Outcome measures
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 Participants
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 Participants
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Incidence of ALLO-501A Related Treatment Emergent Adverse Events
|
1 Participants
|
0 Participants
|
Adverse Events
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lymphodepletion With Fludarabine, Cyclophosphamide, and ALLO-647 (FCA)
n=1 participants at risk
Lymphodepletion with FCA followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine (F) 30 mg/m\^2/day intravenously (IV) on Days -5, -4, -3
* Cyclophosphamide (C) 300 mg/m\^2/ day IV on Days -5, -4, -3
* ALLO-647 (A) 30 mg/day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)
n=1 participants at risk
Lymphodepletion with FC followed by treatment with ALLO-501A arm.
Lymphodepletion:
* Fludarabine 30 mg/m\^2/day IV, on Days -5, -4, -3
* Cyclophosphamide 300 mg/m\^2/ day IV on Days -5, -4, -3
Treatment with ALLO-501A:
• ALLO-501A as a single IV dose of 120 × 10\^6 CAR+ T cells on Day 0
|
|---|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Injury, poisoning and procedural complications
Fall
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Investigations
Electrocardiogram QT prolonged
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
100.0%
1/1 • Number of events 1 • From participant's first dose date of any study drug up to 60 months post ALLO-647 infusion, date of death, date of study discontinuation, or the date of initiation of another anti-cancer agent, whichever occurs first; follow up of the participants ended within 11 months after ALLO-501A infusion due to death as a result of disease progression.
Safety population refers to all participants who received at least one (partial or complete) dose of ALLO-501A or ALLO-647. Aggregate analysis not performed due to small sample size (N=2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place