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AZD0120 dual-target CAR-T (BCMA and CD19) versus standard treatments for relapsed refractory multiple myeloma

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.

Phase 3 Interventional AstraZeneca · NCT07391657

This trial tests whether a dual-target CAR-T therapy called AZD0120 works better than commonly used drug regimens for adults with relapsed or refractory multiple myeloma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment508 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T, daratumumab
Locations111 sites (Gilbert, Arizona and 110 other locations)
Trial IDNCT07391657 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label Phase III trial comparing a dual-target CAR-T cell therapy (AZD0120) against several standard regimens (DKd, DPd, PVd, or Kd) in people with relapsed or refractory multiple myeloma. Eligible adults have 1–3 prior lines of therapy including an IMiD and either a proteasome inhibitor or a CD38 antibody and must have measurable progressive disease. Participants randomized to AZD0120 will undergo leukapheresis for CAR-T manufacturing and receive a single CAR-T infusion, while the comparator arms receive standard multi-agent drug regimens. The trial measures efficacy outcomes and safety across multiple international sites with scheduled follow-up visits to monitor response and adverse events.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsed or refractory multiple myeloma who have 1–3 prior therapy lines including an IMiD and either a proteasome inhibitor or a CD38 antibody, measurable disease, and documented progression are the intended candidates.

Not a fit: Patients with more than three prior lines of therapy, significant medical conditions that preclude CAR-T therapy, or those who cannot undergo leukapheresis and the required inpatient/clinic procedures are less likely to benefit or be eligible.

Why it matters

Potential benefit: If successful, AZD0120 could produce deeper or more durable remissions for people whose myeloma has returned or stopped responding to prior treatments.

How similar studies have performed: BCMA-directed CAR-T therapies have shown high response rates in relapsed/refractory myeloma, but dual BCMA/CD19 CAR-T approaches are newer and less extensively proven in late-phase trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Gilbert, Arizona and 110 other locations

+61 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed Refractory Multiple MyelomaBCMACAR-TCD19
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.