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

Phase 2

Active, not recruiting

• Conditions: Relapsed/Refractory Large B Cell Lymphoma
• Interventions: Biological: ALLO-647; Drug: Fludarabine; Drug: Cyclophosphamide; Genetic: ALLO-501A

• Registration Number: NCT05714345
• Lead Sponsor: Allogene Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-06
• Study Start: 2023-03-31
• Primary Completion: 2024-02-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	ALLO-647	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	ALLO-501A	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with fludarabine and cyclophosphamide	ALLO-501A	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with fludarabine and cyclophosphamide	Fludarabine	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with fludarabine and cyclophosphamide	Cyclophosphamide	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	Cyclophosphamide	ALLO-501A CAR T cells infused following lymphodepletion
Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamide	Fludarabine	ALLO-501A CAR T cells infused following lymphodepletion

Primary Outcome Measures

Name	Time	Method
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 IRC in subjects with R/R (Relapsed / Refractory) LBCL (Large B Cell Lymphoma)	Up to 60 months

Secondary Outcome Measures

Name	Time	Method
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 IRC in subjects with R/R LBCL	Up to 60 months
To assess the clinical efficacy of ALLO-647 as measured by Overall Response Rate (ORR) and assessed by IRC between treatment arms	Up to 60 months
To evaluate the rate of anti-drug antibodies against ALLO-647 and ALLO-501A	Up to 9 months
To evaluate the incidence of treatment-emergent adverse events of ALLO-647 by comparing ALLO-647, fludarabine, and cyclophosphamide (FCA) lymphodepletion with fludarabine and cyclophosphamide (FC) lymphodepletion	Up to 60 months
To evaluate the incidence of treatment-emergent adverse events of ALLO-501A following lymphodepletion	Up to 60 months
To characterize the efficacy of ALLO-647 as measured by Duration of Response (DOR) and assessed by IRC between treatment arms	Up to 60 months
To characterize the efficacy of ALLO-647 as measured by Progression Free Survival (PFS) and assessed by IRC between treatment arms	Up to 60 months
To characterize the efficacy of ALLO-647 as measured by response rate per investigator review	Up to 60 months
To characterize the efficacy of ALLO-647 as measured by DOR and assessed by investigator assessments between treatment arms	Up to 60 months
To characterize the efficacy of ALLO-647 as measured by Overall Survival (OS)	Up to 60 months
To characterize lymphodepletion with and without ALLO-647 as measured by absolute lymphocyte count/microliter; T cell counts/microliter; B cell counts/microliter, NK cell counts/microliter	Up to 9 months
To characterize the serum concentration of ALLO-647 as measured by microgram per microliter	Up to 10 days
To characterize blood concentration of ALLO-501A when administered with lymphodepletion with and without ALLO-647 as measured by vector copy number	Up to 9 months
To characterize the effects of ALLO-647 on host T cell concentrations as measured by T cell counts cells/microliter	Up to 9 months

Trial Locations

Locations (2)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium

University of Louisville James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States