Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab 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 preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must ≥18 years and \< 80 years old. 2. Patients must have received \>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody: • International Myeloma Working Group (IMWG) criteria define 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 chain ≥100 mg/L with abnormal light ch…
Interventions
- BiologicalFT836 CAR T cells (1 x 10^8 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- BiologicalFT836 CAR T cells (3 x 108 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- BiologicalFT836 CAR T cells (up to 9 x 108 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- DrugDaratumumab 16 mg/kg
Daratumumab will be administered intravenously.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin