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

Allogene Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Relapsed/Refractory Large B Cell Lymphoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05714345

ALLO-647-201

Details and patient eligibility

About

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide

Experimental group

Description:

ALLO-501A CAR T cells infused following lymphodepletion

Treatment:

Genetic: ALLO-501A

Biological: ALLO-647

Drug: Cyclophosphamide

Drug: Fludarabine

Lymphodepletion with fludarabine and cyclophosphamide

Experimental group

Description:

ALLO-501A CAR T cells infused following lymphodepletion

Treatment:

Genetic: ALLO-501A

Drug: Cyclophosphamide

Drug: Fludarabine