FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT07221032 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-04-14
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.
Conditions
- Relapse Multiple Myeloma
- Refractory Multiple Myeloma
Interventions
- BIOLOGICAL
-
FT836 CAR T cells (1 x 10^8 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- BIOLOGICAL
-
FT836 CAR T cells (3 x 108 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- BIOLOGICAL
-
FT836 CAR T cells (up to 9 x 108 cells per dose)
FT836 CAR T cells will be administered by IV injection.
- DRUG
-
Daratumumab 16 mg/kg
Daratumumab will be administered intravenously.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Binod Dhakal, MD · Medical College of Wisconsin
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2028-03-31
- Completion
- 2030-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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