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
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: Yes
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
Investigator(s)
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)
Contact us to find out if this trial is right for you.
Contact
Linnea Nichols
650-724-9050
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