Description:
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of
ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Title
- Brief Title: Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA-2)
- Official Title: A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Clinical Trial IDs
- ORG STUDY ID:
ALLO-501A-201
- NCT ID:
NCT04416984
Conditions
- Relapsed/Refractory Large B Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
ALLO-647 | | ALLO-501A, ALLO-647 |
Fludarabine | | ALLO-501A, ALLO-647 |
Cyclophosphamide | | ALLO-501A, ALLO-647 |
Purpose
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of
ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Trial Arms
Name | Type | Description | Interventions |
---|
ALLO-501A, ALLO-647 | Experimental | | - ALLO-647
- Fludarabine
- Cyclophosphamide
|
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at
last relapse.
- At least 1 measurable lesion at time of enrollment.
- Relapsed or refractory disease after at least 2 lines of chemotherapy
- ECOG performance status 0 or 1.
- Absence of donor (product)-specific anti-HLA antibodies (DSA).
- Adequate hematological, renal and liver function.
Exclusion Criteria:
- Current or history of central nervous system (CNS) lymphoma.
- Clinically significant CNS dysfunction
- Any other active malignancy within 3 years prior to enrollment, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Radiation therapy within 2 weeks prior to ALLO-647.
- Prior irradiation to >25% of the bone marrow.
- Donor lymphocyte infusion (DLI) within 30 days prior to ALLO-647.
- Patients unwilling to participate in an extended safety monitoring period
Maximum Eligible Age: | 79 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501A |
Time Frame: | 28 days |
Safety Issue: | |
Description: | Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Allogene Therapeutics |
Trial Keywords
- CAR T
- Cell Therapy
- Allogeneic Cell Therapy
- Cellular Immuno-therapy
- AlloCAR T
- ALLO-501A
- ALLO-647
- LBCL
- Lymphoma
- Large B-Cell Lymphoma
Last Updated
May 13, 2021