AZD0120 CAR-T therapy compared with standard treatment for relapsed or refractory multiple myeloma

Who can take part

• Arm A and B: Participants must be 18 years or older, at the time of signing the ICF
• Arm A and B: Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria
• Arm A and B: Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c) Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio
• Arm A and B: Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator’s determination during or after the most recent line of therapy. Participants who have had only 1 prior line of therapy must have disease that has progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
• Arm A and B: Participant must have received 1 to 3 lines of prior therapy including an IMiD and either a PI or an anti-CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
• Arm A and B: Participant is eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator
• Arm A and B: Participants must have an ECOG performance status score of 0 to 1
• Arm A and B: Adequate organ and bone marrow function

Who cannot take part

• Arm A and B: Participant has active or prior CNS or meningeal involvement of MM
• Arm A and B: Participant has primary refractory MM (no minimal response to any prior therapy)
• Arm A and B: Participant previously received any BCMA-targeted treatment
• Arm A and B: Participant previously received CAR-T or CAR-NK therapy
• Arm A and B: Participant previously received T-cell engager therapy
• Arm A and B: Participant previously received allogeneic stem cell transplant at any time or ASCT within 12 weeks before randomization
• Arm A and B: Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome
• Arm A and B: Participant has significant neurological or psychiatric condition posing risk or impairing evaluation (e.g., severe brain injury, dementia, Parkinson’s, stroke, intracranial hemorrhage, or seizure within 6 months). Stable mild conditions may be eligible at Investigator discretion
• Arm A and B: Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation, including: -Serious active or uncontrolled infection, -Requirement of supplemental oxygen, -Active autoimmune disease or history within 2 years, -Clinically significant gastrointestinal disease (including IBD requiring treatment within 5 years)