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)

Recruiting now · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT07073547

Run by

AstraZeneca

People needed

40

Starts

2025-07-31

Expected to finish

2028-05-26

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Research Site — Denver, Colorado, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Charlottesville, Virginia, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Iowa City, Iowa, United States (enrolling)
• Research Site — Duarte, California, United States (enrolling)
• Research Site — St Louis, Missouri, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Nashville, Tennessee, United States (enrolling)
• Research Site — Rochester, Minnesota, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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