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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

NCT07391657•AstraZeneca

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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

Locations (108)

Research Site

Gilbert, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

La Jolla, California, United States

Research Site

Santa Monica, California, United States

Research Site

Denver, Colorado, United States

Research Site

New Haven, Connecticut, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Atlanta, Georgia, United States

Research Site

Chicago, Illinois, United States

Key Dates

Start Date

February 23, 2026

Primary Completion Date

August 30, 2028

Completion Date

July 29, 2030

Last Updated

March 12, 2026

Enrollment

508

ESTIMATED participants

Conditions

Relapsed Refractory Multiple Myeloma

Interventions

AZD0120

BIOLOGICAL

Daratumumab

DRUG

Carfilzomib

DRUG

Dexamethasone

DRUG

Bortezomib

DRUG

Pomalidomide

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM

Myeloma-Developing Regimens Using Genomics (MyDRUG)