Tests AZD0120 cell therapy in adults with relapsed or refractory multiple myeloma

Trial details

Who runs it

AstraZeneca

Trial code

NCT05850234

Record updated

8 October 2026

Original description

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.Read full original descriptionShow less

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

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.

Inclusion: ≥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: 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; 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; Participant has significant cardiac, neurological, or psychiatric conditions.

ClinicalTrials.gov NCT05850234