EXPAND: Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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]
- 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]
Eligibility Criteria
Criteria
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
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Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
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Adequate hematological, renal and liver function
Exclusion Criteria:
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Active central nervous system involvement by malignancy
-
Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
-
Hypocellular bone marrow for age
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Allogene Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALLO-647-201