Overview

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Eligibility

Inclusion Criteria:

• ≥18 years of age at the time of consent.
• ECOG performance status of 0 or 1.
• Documented diagnosis of MM per IMWG diagnostic criteria.
• Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
• Have documented evidence of progressive disease per IMWG criteria.
• Participant must have measurable disease at screening.
• Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Exclusion Criteria :

• Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
• Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
• Participant has significant cardiac, neurological, or psychiatric conditions.
• Any other significant medical conditions such as:
  • Serious active or uncontrolled infection
  • Active autoimmune disease or a history of autoimmune disease within 2 years
  • Active plasma cell leukemia at the time of screening
  • Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
• Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.