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

Not Recruiting

Trial ID: NCT03939026


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.

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, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Inclusion Criteria:

   - Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular

   - Relapse or refractory disease after at least 2 lines of chemotherapy

   - At least 1 measurable lesion at time of screening.

   - Eastern Cooperative Oncology Group Performance Status of 0 or 1.

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

Exclusion Criteria:

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

   - Clinically significant CNS dysfunction.

   - ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.

   - Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified
   cell therapy or adoptive T cell therapy

   - Systemic anticancer therapy within 2 weeks prior to study entry.

   - On-going treatment with immunosuppressive agents.

   - Active acute or chronic graft versus host disease (GvHD), or GvHD requiring
   immunosuppressive treatment within 4 weeks of enrollment.

   - Any form of primary or acquired immunodeficiency (e.g., severe combined
   immunodeficiency disease).

   - Current thyroid disorder (including hyperthyroidism), except for subjects with
   hypothyroidism controlled on a stable dose of hormone replacement therapy.

   - Patients unwilling to participate in an extended safety monitoring period


genetic: ALLO-501

biological: ALLO-647

drug: Fludarabine

drug: Cyclophosphamide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Nichols

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