Clinical Trial Details
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Phase IInterventional
A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)
Protocol: 2026P000170NCT: NCT07073547
Overview
This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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 minimum of 4 cycles and a maximum of 6 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
