NCT05850234

AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

Detailed description

Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple myeloma and determine the recommended Phase 2 dose of AZD0120. Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of life parameters in subjects with relapsed/refractory multiple myeloma.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	AZD0120	AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

Timeline

• Start date: 2023-07-20
• Primary completion: 2027-08-31
• Completion: 2028-11-14
• First posted: 2023-05-09
• Last updated: 2026-04-06

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study