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

NCT ID: NCT05714345

Last Updated: 2025-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-10-28

Brief Summary

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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

Detailed Description

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Conditions

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Relapsed/Refractory Large B Cell Lymphoma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide

ALLO-501A CAR T cells infused following lymphodepletion

Group Type EXPERIMENTAL

ALLO-647

Intervention Type BIOLOGICAL

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

Fludarabine

Intervention Type DRUG

Chemotherapy for lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for lymphodepletion

ALLO-501A

Intervention Type GENETIC

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

Lymphodepletion with fludarabine and cyclophosphamide

ALLO-501A CAR T cells infused following lymphodepletion

Group Type EXPERIMENTAL

Fludarabine

Intervention Type DRUG

Chemotherapy for lymphodepletion

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for lymphodepletion

ALLO-501A

Intervention Type GENETIC

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

Interventions

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ALLO-647

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

Intervention Type BIOLOGICAL

Fludarabine

Chemotherapy for lymphodepletion

Intervention Type DRUG

Cyclophosphamide

Chemotherapy for lymphodepletion

Intervention Type DRUG

ALLO-501A

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allogene Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Louisville James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Austria United States Belgium

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Original

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with Statistical Analysis Plan Amendment 1

View Document

Other Identifiers

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ALLO-647-201

Identifier Type: -

Identifier Source: org_study_id