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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 (DURGA-2)
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)
Who can join
Ages 18 and older · All sexes
Full eligibility 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 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
About the study
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).
What is being tested
- AZD0120 (biological)
Sponsor: AstraZeneca · Participants: 40 · Started: Jul 31, 2025
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07073547
Locations in the U.S.
| California | Research Site, Duarte |
| Colorado | Research Site, Denver |
| Georgia | Research Site, Atlanta |
| Iowa | Research Site, Iowa City |
| Missouri | Research Site, St Louis |
| New York | Research Site, New York |
| Tennessee | Research Site, Nashville |
| Texas | Research Site, Houston |
| Virginia | Research Site, Charlottesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.