Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Allogene Therapeutics

Stanford Investigator(s):

Intervention(s):

  • Genetic: ALLO-501A
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Phase:

Phase 1/Phase 2

Eligibility


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.

   - 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

Ages Eligible for Study

18 Years - 79 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Bjornlund Nichols
650-724-9050
Recruiting