DURGA-1 Study: AZD0120 for Relapsed/Refractory Multiple Myeloma

This study is testing a new treatment called AZD0120 for adults with multiple myeloma that has come back or is not responding to other treatments (relapsed/refractory multiple myeloma). AZD0120 is a special type of cell therapy (CAR T product) that targets two specific proteins (BCMA and CD19) on cancer cells. To join, you must be at least 18 years old, have a good general health status (ECOG performance status of 0 or 1), and have previously received at least three types of myeloma treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study will look at how safe AZD0120 is and how well it works to shrink or control the cancer. The study is currently recruiting about 182 participants.

Study design
This is an open-label, multicenter study with two phases (Phase 1b and Phase 2) and plans to enroll 182 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least two years after the study begins to assess side effects and how well the treatment works.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05850234

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~232 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AZD0120

At a glance

Recruiting sites
33 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b: Adverse Events (AEs)
Measured over Through study completion, a minimum of 2 years.
+2 more outcomes measured
Relapsed/Refractory Multiple Myeloma
36 sites across 21 states
California3
Florida3
New York3
Texas3
Colorado2
Massachusetts2
Michigan2
Minnesota2
AstraZeneca Clinical Study Information Center
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Eligibility criteria

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.
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.
  • Phase 1b: Adverse Events (AEs)Through study completion, a minimum of 2 years.

    The incidence and severity of AEs.

  • Phase 1b: Dose-Limiting Toxicities (DLTs)28 days

    The DLT evaluation period is defined as the first 28 days after infusion.

  • Phase 2: Objective Response Rate (ORR)Through study completion, a minimum of 2 years.

    Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.