Clinical Trials /

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

NCT03939026

Description:

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

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

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
  • Official Title: A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: ALLO-501-201
  • NCT ID: NCT03939026

Conditions

  • Relapsed/Refractory Large B Cell Lymphoma
  • Relapsed/Refractory Follicular Lymphoma

Interventions

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

Purpose

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Trial Arms

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

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically proven relapsed or refractory aggressive large B-cell lymphoma or
             follicular lymphoma with at least one measurable lesion

          -  At least 2 prior lines of therapies including an anthracycline and an anti-CD20
             monoclonal antibody for large B-cell lymphoma and an anti-CD20 monoclonal antibody for
             follicular lymphoma

          -  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 or any anti-CD19 therapies that
             include the 4G7 scFv clone

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

          -  Patients unwilling to participate in an extended safety monitoring period
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Time Frame:28 days
Safety Issue:
Description:Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion

Secondary Outcome Measures

Measure:Incidence and severity of adverse events with ALLO-501 and ALLO-647 in combination with fludarabine/cyclophosphamide
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Cellular kinetics of ALLO-501
Time Frame:Up to 9 months
Safety Issue:
Description:Levels of Anti-CD19 CAR T Cells in Blood
Measure:Pharmacokinetics of ALLO-647
Time Frame:Up to 9 months
Safety Issue:
Description:Serum concentration levels of ALLO-647
Measure:Incidence of immunogenicity against ALLO-501 and ALLO-647
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Immune monitoring after lymphodepletion regimen
Time Frame:Up to 9 months
Safety Issue:
Description:Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells
Measure:Overall Response Rate
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Duration of response
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Progression-free survival
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Time to Response
Time Frame:Up to 9 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 9 months
Safety Issue:
Description:

Details

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

Last Updated

January 8, 2020