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)

Sponsor: Allogene Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04416984

Patient View

The ALPHA2 study is a Phase 1/2 trial assessing the safety and efficacy of ALLO-501A, an allogeneic CAR T cell therapy, in adults with R/R LBCL and CLL/SLL. Eligible participants must have relapsed/refractory disease, meet specific health criteria, and undergo a lymphodepletion regimen with fludarabine, cyclophosphamide, and ALLO-647 before receiving ALLO-501A.

Patient Parameters

Program Overview

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 Criteria

Inclusion Criteria

For subjects with LBCL:

  • Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017
  • At least 1 measurable lesion at time of enrollment
  • Relapsed or refractory disease after at least 2 lines of chemotherapy
  • Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2)

For subjects with CLL/SLL:

  • Diagnosis of CLL/SLL
  • Relapsed/refractory disease
  • Subjects relapsed/refractory to BTKi therapy and high-risk disease
  • Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax)
  • At least 1 measurable lesion at time of enrollment

For all subjects:

  • Male or female subjects ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Adequate hematological, renal, and liver function

Exclusion Criteria

  • Active central nervous system (CNS) involvement by malignancy
  • Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
  • Any other active malignancies that required systemic treatment within 3 years prior to enrollment
  • Radiation therapy within 2 weeks prior to ALLO-647
  • Prior irradiation to >25% of the bone marrow
  • Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2).
  • Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)
  • Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

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