A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

Recruiting now · Phase 3

Conditions studied: Relapsed Refractory Multiple Myeloma

In brief

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Key facts

Study ID: NCT07391657
Run by: AstraZeneca
People needed: 508
Starts: 2026-02-23
Expected to finish: 2030-07-29
Last updated by the study team: 2026-08-06

Who can join

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

You may qualify if…

Age ≥ 18 years
Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
Documented evidence of measurable disease:
Serum M-protein level ≥ 1 g/dL
Urine M-protein level ≥ 200 mg/24h
Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
ECOG performance status score of 0 to 1
Adequate hematology and chemistry laboratory values:
Haemoglobin ≥ 8.0 g/dL
Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)
Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

You may not qualify if…

Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
Significant neurological or psychiatric condition
Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
Previously received any prior BCMA-targeted treatment
Previously received CAR-T or CAR-NK therapy directed at any target
Previously received T-cell engager therapy directed at any target
Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

Where it is running

Research Site — São Paulo, Brazil (enrolling)
Research Site — Shibuya-ku, Japan (enrolling)
Research Site — Houston, Texas, United States (enrolling)
Research Site — Salvador, Brazil (enrolling)
Research Site — Kashiwa, Japan (enrolling)
Research Site — Nagoya, Japan (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — Austin, Texas, United States (enrolling)
Research Site — Darlinghurst, Australia (enrolling)
Research Site — Melbourne, Australia (enrolling)
Research Site — Montreal, Quebec, Canada (enrolling)
Research Site — Bunkyō City, Japan (enrolling)
Research Site — Denver, Colorado, United States (enrolling)
Research Site — Kyoto, Japan (enrolling)
Research Site — New Haven, Connecticut, United States (enrolling)
Research Site — Louisville, Kentucky, United States (enrolling)
Research Site — New York, New York, United States (enrolling)
Research Site — Nashville, Tennessee, United States (enrolling)
Research Site — Seattle, Washington, United States (enrolling)
Research Site — Camperdown, Australia (enrolling)
Research Site — Fitzroy, Australia (enrolling)
Research Site — Melbourne, Australia (enrolling)
Research Site — São Paulo, Brazil (enrolling)
Research Site — Toronto, Ontario, Canada (enrolling)
Research Site — Shinjuku-ku, Japan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.