BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)

This is dose level 1, the starting dose.

The maximum tolerated dose is yet to be determined.

BCMA-Transforming growth factor-beta (TGFβ) CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Patients will receive one of three dose levels of BCMA-TGFβ CAR-T cells based on our dose escalation design.

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.

Live record on ClinicalTrials.gov →

• 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) 38 monoclonal antibody:
• 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:
• Serum M-protein ≥0.5 g/dl;
• Urine M-protein ≥200 mg/24 hrs;

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.