A Phase III Study Comparing AZD0120 Dual-targeting CAR-T Therapy to Standard Treatments in Relapsed Refractory Multiple Myeloma Patients

What this Trial Is About

Researchers are evaluating AZD0120, a dual-targeted CAR-T therapy aimed at BCMA and CD19, compared with standard treatment regimens for participants with relapsed refractory multiple myeloma RRMM. This Phase III, randomized, open-label global study aims to assess how AZD0120 performs relative to established therapies including DKd, DPd, PVd, or Kd. The study focuses on participants who have received previous treatments and now require additional therapy due to disease progression. Participants will receive either AZD0120 or one of four standard regimens chosen by their investigator, including combinations of daratumumab, carfilzomib, pomalidomide, bortezomib, and dexamethasone. The treatment period and dosing depend on the assigned regimen, and the study compares these approaches over time. The trial is designed to measure progression-free survival and response rates to evaluate the benefits of AZD0120 compared to standard care. During the study, participants will undergo regular assessments to monitor disease status and treatment effects. These include laboratory tests to measure disease markers, imaging, and safety evaluations. The primary outcomes include progression-free survival over three years and minimal residual disease negativity at nine months. Secondary outcomes assess response rates and overall survival over several years. The study duration extends up to 2030 with ongoing monitoring and follow-up to collect comprehensive data on participant health and treatment impact.

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)