Phase I Study of BCMA-TGF-BETA Insensitive Armored CAR T Cells in Patients With Relapsed and/or Refractory Multiple Myeloma
Medical College of Wisconsin
Summary
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.
Description
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. After the maximal tolerated dose (MTD) is determined, an additional dose-expansion cohort of up to 9 patients (3 BCMA-naïve and 6 BCMA exposed) may be enrolled at that dose to further describe the safety and preliminary efficacy of that dose.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must be aged ≥18 years to 80 years old. 2. 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. 3. Patients must have measurable disease, including at least one or more of the following criteria: 1. Serum M-protein ≥0.5 g/dl; 2. Urine M-protein ≥200 mg/24 hrs; 3. Involved serum light chai…
Interventions
- BiologicalBCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
This is dose level 0 (de-escalation).
- BiologicalBCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
This is dose level 1, the starting dose.
- BiologicalBCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
This is dose level 2.
- BiologicalBCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
This is dose level 3.
- BiologicalMaximum tolerated dose
The maximum tolerated dose is yet to be determined.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin