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.