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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
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