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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Up to 60 months

Results posted on

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

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

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

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 months

Population: 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 months

Population: 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

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 months

Population: 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 months

Population: 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

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

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

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

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

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

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)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Lymphodepletion With Fludarabine, and Cyclophosphamide (FC)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Medical Information

Allogene Therapeutics, Inc

Phone: (+1) 415-604-5696

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place