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

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.

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)

Eligibility

Inclusion Criteria:

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

Intervention(s):

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
650-724-9050

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