FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refract… (NCT07221032) | Clinical Trial Compass
Not Yet RecruitingPhase 1
FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
United States12 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients must ≥18 years and \< 80 years old.
✓. Patients must have received \>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:
✓. Patients must have measurable disease, including at least one or more of the following criteria:
✕. Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.
✕. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
✕. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \>20 mg of prednisone or equivalent daily.
✕. Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
What they're measuring
1
Incidence of Grade 3 or higher adverse events
Timeframe: start of therapy through 30 days after the end of study therapy, up to 2 years
Trial details
NCT IDNCT07221032
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2028-03
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
. Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.
✕. Refusal to participate in the long-term follow-up protocol.
✕. Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.
✕. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \<6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.