Summary

Eligibility
for people ages 18-79 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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.

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)

Keywords

Relapsed/Refractory Large B Cell Lymphoma CAR T Cell Therapy Allogeneic Cell Therapy Cellular Immuno-therapy AlloCAR T ALLO-501A ALLO-647 LBCL Lymphoma Large B-Cell Lymphoma Lymphoma, B-Cell Cyclophosphamide Fludarabine ALLO-501A, ALLO-647

Eligibility

You can join if…

Open to people ages 18-79

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allogene Therapeutics
ID
NCT04416984
Phase
Phase 1/2
Study Type
Interventional
Last Updated