AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05850234

Run by

AstraZeneca

People needed

182

Starts

2023-07-20

Expected to finish

2028-11-14

Last updated by the study team

2026-06-23

Who can join

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

You may qualify if…

• ≥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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Milwaukee, Wisconsin, United States (enrolling)
• Research Site — Phoenix, Arizona, United States (enrolling)
• Research Site — La Jolla, California, United States (enrolling)
• Research Site — Los Angeles, California, United States (enrolling)
• Research Site — San Francisco, California, United States (enrolling)
• Research Site — Aurora, Colorado, United States (enrolling)
• Research Site — Denver, Colorado, United States (enrolling)
• Research Site — Jacksonville, Florida, United States (enrolling)
• Research Site — Miami, Florida, United States (enrolling)
• Research Site — Tampa, Florida, United States (enrolling)
• Research Site — Atlanta, Georgia, United States (enrolling)
• Research Site — Chicago, Illinois, United States (enrolling)
• Research Site — Iowa City, Iowa, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Research Site — Ann Arbor, Michigan, United States (enrolling)
• Research Site — Detroit, Michigan, United States (enrolling)
• Research Site — Minneapolis, Minnesota, United States (enrolling)
• Research Site — Rochester, Minnesota, United States (enrolling)
• Research Site — Edmonds, Washington, United States (enrolling)
• Research Site — Seattle, Washington, United States (enrolling)
• Research Site — Birmingham, Alabama, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Stony Brook, New York, United States (enrolling)
• Research Site — Charlotte, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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