Phase 1: testing FT836 CAR T cells (1 x 10^8 cells per dose) for Relapse Multiple Myeloma

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose), or FT836 CAR T cells (up to 9 x 108 cells per dose). The registry lists allocation as randomized. This is a phase I, treatment, single-arm, open-label, dose-finding treatment study designed to measure the safety and preliminary how well it works of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.

They plan to enroll about 12 people at Milwaukee. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose), FT836 CAR T cells (up to 9 x 108 cells per dose), Daratumumab 16 mg/kg

Primary outcome (registry wording): Incidence of Grade 3 or higher adverse events

Who it is for (from inclusion criteria)

• Ages 18 Years to 80 Years
• 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:
• International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy
• Patients must have measurable disease, including at least one or more of the following criteria:
• Serum M-protein ≥ 0.5 g/dl;
• Urine M-protein ≥ 200 mg/24 hrs;
• Involved serum light chain ≥100 mg/L with abnormal light chain ratio;