Study Comparing AZD0120, a Dual-targeted CAR-T Therapy, with Standard Treatments for Relapsed Refractory Multiple Myeloma (DURGA-4)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07391657

Provider View

This clinical trial is testing a new CAR-T cell therapy, AZD0120, which targets two proteins, BCMA and CD19, against standard treatments for patients with relapsed or refractory multiple myeloma. The study aims to compare the effectiveness and safety of these treatments.

Patient Parameters

Program Overview

This study is a global Phase III trial that compares the new CAR-T cell therapy, AZD0120, which targets BCMA and CD19, with standard treatment options for patients with relapsed or refractory multiple myeloma (RRMM). The standard treatments include combinations of drugs like daratumumab, carfilzomib, pomalidomide, bortezomib, and dexamethasone. The trial will assess which treatment is more effective and safer for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma.
  • Have measurable disease, such as specific levels of M-protein in blood or urine.
  • Disease must have progressed after the most recent treatment.
  • Have received 1 to 3 previous treatments, including specific types of drugs.
  • Eligible to receive at least one of the standard treatment regimens.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate blood counts and organ function based on specific lab tests.

Exclusion Criteria

  • Have or had cancer spread to the brain or spinal cord.
  • Have certain other blood disorders like amyloidosis or plasma cell leukemia.
  • Did not respond to any previous treatments for multiple myeloma.
  • Have significant neurological or psychiatric conditions.
  • Have a medical condition that increases the risk of treatment complications.
  • Have previously received treatments targeting BCMA or CAR-T therapies.
  • Have had a stem cell transplant recently or certain types of transplants in the past.

Locations

FACILITYZIPCITYSTATE
Research Site85234GilbertArizona
Research Site85054PhoenixArizona
Research Site85719TucsonArizona
Research Site92093La JollaCalifornia
Research Site95817SacramentoCalifornia
Research Site90404Santa MonicaCalifornia
Research Site80218DenverColorado
Research Site06510New HavenConnecticut
Research Site20007Washington D.C.District of Columbia
Research Site33156Coral GablesFlorida

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