FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07221032
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Refractory Multiple Myeloma
  • Relapse Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • FT836 CAR T cells (1 x 10^8 cells per dose) — BIOLOGICAL
    FT836 CAR T cells will be administered by IV injection.
  • FT836 CAR T cells (3 x 108 cells per dose) — BIOLOGICAL
    FT836 CAR T cells will be administered by IV injection.
  • FT836 CAR T cells (up to 9 x 108 cells per dose) — BIOLOGICAL
    FT836 CAR T cells will be administered by IV injection.
  • Daratumumab 16 mg/kg — DRUG
    Daratumumab will be administered intravenously.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: FT836 CAR T cells (1 x 10^8 cells per dose)
    This is Dose Level 0 (de-escalation dose).
  • Experimental: FT836 CAR T cells (3 x 108 cells per dose)
    This is Dose Level 1 (starting dose).
  • Experimental: FT836 CAR T cells (up to 9 x 108 cells per dose)
    This is Dose Level 2, which is ≤3 times Dose Level 1.

Primary Outcome Measure

Incidence of Grade 3 or higher adverse events [ Time Frame: start of therapy through 30 days after the end of study therapy, up to 2 years ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Binod Dhakal, MD
[email protected]
414-805-4600

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By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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