Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Fludarabine: Chemotherapy for lymphodepletion

Cyclophosphamide: Chemotherapy for lymphodepletion

Study summary

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Eligibility

Primary outcome measure(s)

• Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A — 28 days
  Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion
• Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A — 33 days
  DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
• Phase 1b: Frequency and severity of ALLO-501A treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest — Up to 60 months
• Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC) — Up to 60 months
  ORR defined as assessment of CR and PR using Lugano classification criteria 2014

Trial sites (29)