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

NCT05714345 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ALLO-647-201
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Relapsed/Refractory Large B Cell Lymphoma

Keywords

CAR T; Cell Therapy; Allogeneic Cell Therapy; Cellular Immuno-therapy; AlloCAR T; ALLO-501A; ALLO-647; LBCL; Lymphoma; Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) of a Lymphodepletion Regimen Containing FCA vs FC Alone Per Independent Review Committee

  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 Outcomes (9)

• Overall-response Rate (ORR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee

  Up to 60 months

• Event-Free-Survival (EFS) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee

  Up to 60 months

• Duration of Response (DOR) of a Lymphodepletion Regimen Containing FCA vs FC Per Independent Review Committee

  Up to 60 months

• Overall Survival (OS) of a Lymphodepletion Regimen Containing FCA vs FC

  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

  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.

Study Arms (2)

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide

EXPERIMENTAL

ALLO-501A CAR T cells infused following lymphodepletion

Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: ALLO-501A

Lymphodepletion with fludarabine and cyclophosphamide

EXPERIMENTAL

ALLO-501A CAR T cells infused following lymphodepletion

Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: ALLO-501A

Interventions

ALLO-501A GENETIC

ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide; Lymphodepletion with fludarabine and cyclophosphamide

ALLO-647 BIOLOGICAL

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide

Fludarabine DRUG

Chemotherapy for lymphodepletion

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide; Lymphodepletion with fludarabine and cyclophosphamide

Cyclophosphamide DRUG

Chemotherapy for lymphodepletion

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide; Lymphodepletion with fludarabine and cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allogene Therapeutics: lead

Study Sites (2)

University of Louisville James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Recurrence; Lymphoma

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Limitations and Caveats

ALLO-647-201 (EXPAND) was a Phase 2 study that was terminated prior to completion for reasons not related to safety or efficacy concerns. No analyses of the baseline, disposition, safety, primary, secondary, nor exploratory endpoints were performed due to the limited enrollment and data collected during the study. Data were listed but not summarized.

Results Point of Contact

• Title: Medical Information
• Organization: Allogene Therapeutics, Inc

clinicaltrials@allogene.com

(+1) 415-604-5696

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: February 6, 2023
• Study Start: November 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: October 28, 2024
• Last Updated: March 2, 2026
• Results First Posted: December 31, 2025

Record last verified: 2026-02

Locations

US (1); BE (1)