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

• 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

• Have received prior treatment with CAR T therapy directed at any target

• Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

• Stroke or seizure within 6 months of signing informed consent

• Active or history of plasma cell leukemia at the time of screening

• Seropositive for human immunodeficiency virus (HIV)

• Active Hepatitis B

• Hepatitis C infection

• Serious underlying medical condition, such as:

  • Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
  • Active autoimmune disease or a history of autoimmune disease within 3 years
  • Overt clinical evidence of dementia or altered mental status