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RecruitingInterventionalPhase 3

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.

NCT ID: NCT07391657Sponsor: AstraZenecaLast updated: 2026-06-11

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.

Arms & interventions

  • BiologicalAZD0120

    CAR-T Cells

  • DrugDaratumumab

    Daratumumab

  • DrugCarfilzomib

    Carfilzomib

  • DrugDexamethasone

    Dexamethasone

  • DrugBortezomib

    Bortezomib

  • DrugPomalidomide

    Pomalidomides

Outcome measures

Primary

  • To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.

    PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.

    Time frame: 3 years

  • To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.

    MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.

    Time frame: 2 years

Secondary

  • To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.

    Time frame: 2 years

  • To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.

    Time frame: 2 years

  • To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.

    Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (48)

Research Site

Gilbert, Arizona, 85234

Not Yet Recruiting

Research Site

Phoenix, Arizona, 85054

Withdrawn

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Tucson, Arizona, 85719

Not Yet Recruiting

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La Jolla, California, 92093

Withdrawn

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Sacramento, California, 95817

Not Yet Recruiting

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Santa Monica, California, 90404

Not Yet Recruiting

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Denver, Colorado, 80218

Not Yet Recruiting

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New Haven, Connecticut, 06510

Recruiting

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Washington D.C., District of Columbia, 20007

Not Yet Recruiting

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Coral Gables, Florida, 33156

Not Yet Recruiting

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Tampa, Florida, 33606

Not Yet Recruiting

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Atlanta, Georgia, 30322

Not Yet Recruiting

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Chicago, Illinois, 60612

Not Yet Recruiting

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Park Ridge, Illinois, 60068

Not Yet Recruiting

Research Site

Iowa City, Iowa, 52242

Withdrawn

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Kansas City, Kansas, 66160

Not Yet Recruiting

Research Site

Louisville, Kentucky, 40207

Not Yet Recruiting

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Boston, Massachusetts, 02114

Not Yet Recruiting

Research Site

Boston, Massachusetts, 02215

Not Yet Recruiting

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Boston, Massachusetts, 02215

Withdrawn

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Detroit, Michigan, 48201

Withdrawn

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Detroit, Michigan, 48202

Withdrawn

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Rochester, Minnesota, 55905

Withdrawn

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Albany, New York, 12208

Not Yet Recruiting

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New York, New York, 10016

Withdrawn

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New York, New York, 10029

Not Yet Recruiting

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New York, New York, 10065

Withdrawn

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New York, New York, 10065

Not Yet Recruiting

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Rochester, New York, 14642

Withdrawn

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The Bronx, New York, 10467

Withdrawn

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Chapel Hill, North Carolina, 27514

Not Yet Recruiting

Research Site

Charlotte, North Carolina, 28204

Not Yet Recruiting

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Winston-Salem, North Carolina, 27103

Not Yet Recruiting

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Cincinnati, Ohio, 45220

Not Yet Recruiting

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Cleveland, Ohio, 44195

Not Yet Recruiting

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Portland, Oregon, 97239

Not Yet Recruiting

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Charleston, South Carolina, 29425

Withdrawn

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Nashville, Tennessee, 37203

Not Yet Recruiting

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Austin, Texas, 78704

Not Yet Recruiting

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Dallas, Texas, 75235

Not Yet Recruiting

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Houston, Texas, 77030

Not Yet Recruiting

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Salt Lake City, Utah, 84112

Not Yet Recruiting

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Charlottesville, Virginia, 22908

Withdrawn

Research Site

Gainesville, Virginia, 20155

Not Yet Recruiting

Research Site

Richmond, Virginia, 23298

Withdrawn

Research Site

Seattle, Washington, 98104

Recruiting

Research Site

Madison, Wisconsin, 53792

Not Yet Recruiting

Research Site

Milwaukee, Wisconsin, 53226

Not Yet Recruiting