Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies.

Trial Details

NCT ID
NCT05976555
Phase
PHASE1
Sponsor
Medical College of Wisconsin
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
  • BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
  • BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
  • BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
  • Maximum tolerated dose
Locations (sample)
  • Milwaukee, Wisconsin, United States|43.0389,-87.90647

Key Eligibility Criteria

  • Patients must be aged ≥18 years to 80 years old.
  • Patients must have received three prior lines of therapies, including proteasome inhibitor, immunomodulator and a cluster of differentiation (CD) 3…
  • International Myeloma Working Group (IMWG) criteria defines refractory disease as disease progression on or within 60 days of receiving therapy.
  • Patients must have measurable disease, including at least one or more of the following criteria:

For full eligibility, visit ClinicalTrials.gov.

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