A Phase 1b/2 Study of GC012F (AZD0120), a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
• Males and females ≥18 years of age at the time of consent
• Written informed consent in accordance with federal, local, and institutional guidelines
• Have an ECOG performance status of 0 or 1
• Documented diagnosis of MM per IMWG diagnostic criteria
• Received at least three prior MM treatment lines of therapy
• Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.
• Have documented evidence of progressive disease by the IMWG criteria.
• Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.
• Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP