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

Trial ID or NCT#

NCT03939026

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Linnea Nichols
650-724-9050

View on ClinicalTrials.gov