Clinical Trials /

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA-2)

NCT04416984

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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 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

DrugSynonymsArms
ALLO-647ALLO-501A, ALLO-647
FludarabineALLO-501A, ALLO-647
CyclophosphamideALLO-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

NameTypeDescriptionInterventions
ALLO-501A, ALLO-647Experimental
  • ALLO-647
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed relapsed/refractory large B-cell lymphoma with at least one
             measurable lesion

          -  At least 2 prior lines of chemotherapy including an anthracycline and an anti-CD20
             monoclonal antibody

          -  Prior CD19 therapy allowed with evidence of CD19 positive relapse following any prior
             CD19-directed therapy, including cell therapies

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Absence of donor (product)-specific anti-HLA antibodies

          -  Adequate hematological, renal, liver, pulmonary, and cardiac functions

        Exclusion Criteria:

          -  Current or history of central nervous system (CNS) lymphoma

          -  Clinically significant CNS dysfunction

          -  Current thyroid disorder (including hyperthyroidism) with the exception of
             hypothyroidism controlled on stable dose of hormone replacement therapy

          -  Prior treatment with any anti-CD52 monoclonal antibody

          -  Active acute or chronic graft versus host disease (GVHD)

          -  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

Secondary Outcome Measures

Measure:Phase 1 and 2: Incidence and severity of adverse events with ALLO-501A and ALLO-647 in combination with fludarabine/cyclophosphamide
Time Frame:up to 13 months
Safety Issue:
Description:
Measure:Phase 1 and 2: Cellular kinetics of ALLO-501A in target tissues
Time Frame:up to 13 months
Safety Issue:
Description:Levels of Anti-CD19 CAR T cells in blood
Measure:Phase 1 and 2: Pharmacokinetics of ALLO-647
Time Frame:up to 13 months
Safety Issue:
Description:Serum concentration levels of ALLO-647
Measure:Phase 1 and 2: Immunogenicity against ALLO-501A and ALLO-647
Time Frame:up to 13 months
Safety Issue:
Description:Detection of antibodies in blood against ALLO-501A and ALLO-647
Measure:Phase 1 and 2: Immune monitoring after lymphodepletion regimen
Time Frame:up to 13 months
Safety Issue:
Description:Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Measure:Phase 2: Overall response rate
Time Frame:up to 13 months
Safety Issue:
Description:Overall response rate per investigator assessment
Measure:Phase 2: Time to response
Time Frame:up to 13 months
Safety Issue:
Description:
Measure:Phase 2: Duration of Response
Time Frame:up to 13 months
Safety Issue:
Description:
Measure:Phase 2: Progression free survival
Time Frame:up to 13 months
Safety Issue:
Description:
Measure:Phase 2: Overall survival
Time Frame:up to 13 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Allogene Therapeutics

Last Updated

June 2, 2020