Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
Trial Parameters
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Brief Summary
This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.
Eligibility Criteria
Inclusion Criteria: 1. Ability of participant to understand this study, and participant willingness to sign a written informed consent 2. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen 3. Patients must have histologically confirmed aggressive B-Cell NHL or ALL as stated below: A. Patients with relapsed or refractory B-Cell ALL i. Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry. ii. Patients with relapsed/refractory disease in blood, marrow, and extramedullary sites including CSF will be eligible when there is immunophenotypic evidence of CD19 and/or CD20 and/or CD22 expression iii. Primary refractory disease at study entry defined as: A morphologic complete response has never been achieved prior to study entry. iv. Early first relapse at study entry defined as: Disease recurrence by morphologic assess