A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Early-Line Treatment in Subjects with Multiple Myeloma

Inclusion Criteria

• - Males and females ≥18 years of age at the time of consent
• - Documented diagnosis of multiple myeloma (MM) per IMWG diagnostic criteria
• - Have an ECOG performance status of 0 or 1
• - Documented diagnosis of MM per IMWG diagnostic criteria
• - Subjects must have measurable disease per IMWG criteria, defined as:
• • Serum monoclonal paraprotein (M-protein) ≥1.0 g/dL (10 g/L)
• • Urine M-protein ≥200 mg/24 h
• • Serum free light chain (FLC) assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal
• - Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the clinical trial protocol
• - Patients with a previously treated malignancy other than MM if treatment of that malignancy was completed greater than 2 years before screening and the patient has no evidence of disease at the time of screening
• For NDMM subjects:
• - Newly diagnosed multiple myeloma (NDMM) without prior anti-myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable) * Induction therapy: bortezomib based triplet regimen, with or without anti-CD38 antibody, such as VRD Bortezomib/Lenalidomide/Dexamethasone, DVRd-Daratumumab/lenalidomide/bortezomib/dexamethasone, etc., as NCCN Guidelines preferred or recommended standard of care therapies, which is determined by the investigator based on the patient's condition
• - Classified as high-risk MM
• For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) subjects:
• - Have received and failed 1 or 2 lines of anti-myeloma therapy
• - Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
• - Have documented evidence of progressive disease based on investigator’s determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject’s last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen