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Clinical Trials in the UK / NCT07391657
Recruiting Phase 3

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)

NCT07391657 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-02-23
Last updated
2026-09-01

Condition(s) studied

Relapsed Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

AZD0120DaratumumabCarfilzomibDexamethasoneBortezomibPomalidomide

AZD0120: CAR-T Cells

Daratumumab: Daratumumab

Carfilzomib: Carfilzomib

Dexamethasone: Dexamethasone

Bortezomib: Bortezomib

Pomalidomide: Pomalidomides

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. 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: 1. Haemoglobin ≥ 8.0 g/dL 2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3) 3. 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 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 5. 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (143)

FacilityCityRegionStatus
Research Site Gilbert Arizona Not Yet Recruiting
Research Site Phoenix Arizona Withdrawn
Research Site Tucson Arizona Not Yet Recruiting
Research Site La Jolla California Withdrawn
Research Site Sacramento California Not Yet Recruiting
Research Site Santa Monica California Not Yet Recruiting
Research Site Denver Colorado Recruiting
Research Site New Haven Connecticut Recruiting
Research Site Washington D.C. District of Columbia Not Yet Recruiting
Research Site Coral Gables Florida Withdrawn
Research Site Tampa Florida Not Yet Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Park Ridge Illinois Not Yet Recruiting
Research Site Iowa City Iowa Withdrawn
Research Site Kansas City Kansas Not Yet Recruiting
Research Site Louisville Kentucky Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Boston Massachusetts Withdrawn
Research Site Detroit Michigan Withdrawn
Research Site Detroit Michigan Withdrawn
Research Site Rochester Minnesota Withdrawn
Research Site Albany New York Not Yet Recruiting
Research Site New York New York Withdrawn
Research Site New York New York Recruiting
Research Site New York New York Withdrawn
Research Site New York New York Recruiting
Research Site Rochester New York Withdrawn
Research Site The Bronx New York Withdrawn
Research Site Chapel Hill North Carolina Not Yet Recruiting
Research Site Charlotte North Carolina Not Yet Recruiting
Research Site Charlotte North Carolina Recruiting
Research Site Winston-Salem North Carolina Recruiting
Research Site Winston-Salem North Carolina Not Yet Recruiting
Research Site Cincinnati Ohio Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Portland Oregon Not Yet Recruiting
Research Site Charleston South Carolina Withdrawn
Research Site Nashville Tennessee Recruiting

+ 103 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391657 on ClinicalTrials.gov ↗ ← All trials in the UK