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.
Patients must ≥18 years and < 80 years old.
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;
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.
Sequential
FT836 CAR T cells (1 x 10^8 cells per dose)
Biological/VaccineFT836 CAR T cells will be administered by IV injection.
FT836 CAR T cells (3 x 108 cells per dose)
Biological/VaccineFT836 CAR T cells will be administered by IV injection.
FT836 CAR T cells (up to 9 x 108 cells per dose)
Biological/VaccineFT836 CAR T cells will be administered by IV injection.
Daratumumab 16 mg/kg
DrugDaratumumab will be administered intravenously.
Incidence of Grade 3 or higher adverse events
This measure is the number of Grade 3 or higher adverse events possibly, probably, or definitely related to the study therapy. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded and assessed using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading systems. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded and assessed using the ASTCT panel guidelines.
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