NCT07073547

A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)

A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).

Detailed description

This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	AZD0120	AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma

Timeline

• Start date: 2025-07-31
• Primary completion: 2028-05-26
• Completion: 2028-05-26
• First posted: 2025-07-18
• Last updated: 2026-03-31

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study