Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy (EXPAND)

February 26, 2026 updated by: Allogene Therapeutics

A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • ECOG performance status 0 or 1
  • Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Active central nervous system involvement by malignancy
  • Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
  • Hypocellular bone marrow for age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
Biological: ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
Experimental: Lymphodepletion with fludarabine and cyclophosphamide
ALLO-501A CAR T cells infused following lymphodepletion
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee
Time Frame: Up to 60 months

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.
Up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time Frame: Up to 60 months

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.
Up to 60 months
Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time Frame: Up to 60 months

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.
Up to 60 months
Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee
Time Frame: Up to 60 months

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.
Up to 60 months
Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC
Time Frame: 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.
To characterize the efficacy of ALLO-647 as measured by OS, defined as the time from randomization to death.
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.
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
Time Frame: 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.

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.
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.
Overall Response Rate of a Lymphodepletion Regimen Containing FCA vs FC Based on Response Assessment Per Investigator Review
Time Frame: 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.

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.
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.
Depth and Duration of a Lymphodepletion Regimen Containing FCA vs FC
Time Frame: 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.
To characterize the depth and duration of lymphodepletion with and without ALLO-647, as assessed by lymphocyte count.
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.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: 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.
To evaluate the overall safety profile of ALLO-647 by comparing FCA lymphodepletion with FC lymphodepletion.
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.
Incidence of ALLO-501A Related Treatment Emergent Adverse Events
Time Frame: 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.
To evaluate the overall safety profile of ALLO-501A following lymphodepletion.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allogene Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

February 20, 2024

Study Completion (Actual)

October 28, 2024

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-647-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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