Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies

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 initia

Trial Details

NCT ID
NCT06879340
Phase
PHASE1
Sponsor
University of Kansas Medical Center
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • DuoCAR20.19.22-D95
  • Fludarabine (Conditional therapy)
  • Cyclophosphamide (Conditional therapy)
Locations (sample)
  • Westwood, Kansas, United States|39.04056,-94.6169

Key Eligibility Criteria

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent
  • Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen
  • 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 e…

For full eligibility, visit ClinicalTrials.gov.

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