Open Actively Recruiting

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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Current or history of central nervous system (CNS) lymphoma.
  • 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

Join this Trial

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Study Stats
Protocol No.
20-000504
Category
Hematology-Oncology
Oncology
Contact
Sebastian Paiz
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04416984
For detailed technical eligibility, visit ClinicalTrials.gov.