A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants with Multiple Myeloma

Inclusion Criteria

• Inclusion Criteria:
• Age:
• • Males and females ≥18 years of age at the time of consent
• Type of Participant and Disease Characteristics:
• • Participant must have documented diagnosis of MM per IMWG diagnostic criteria
• • ECOG performance status of 0 or 1.
• • Adequate organ and bone marrow function.
• For NDMM participants:
• • Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
• • For participants on Module 2: Newly diagnosed MM with a maximum of 6 cycles and minimum of 4 cycles of induction therapy completed prior to screening
• • Classified as high-risk MM
• For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
• • 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
• General Exclusion Criteria:
• • 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
• • Active or history of plasma cell leukemia at the time of screening
• • Seropositive for human immunodeficiency virus (HIV)
• • Active Hepatitis B infection
• • Active Hepatitis C infection
• • Serious underlying medical condition