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Recruiting Phase 1

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)

NCT07073547 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-07-31
Last updated
2026-09-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

AZD0120 →

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Age: * Males and females ≥18 years of age at the time of consent Type of Participant and Disease Characteristics: * Participant must have documented diagnosis of MM per IMWG diagnostic criteria * ECOG performance status of 0 or 1. * Adequate organ and bone marrow function. For NDMM participants: * Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable) * For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening * Classified as high-risk MM For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants: * Have received and failed 1 or 2 lines of anti-myeloma therapy * Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy * Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen General Exclusion Criteria: * Have received prior treatment with CAR T therapy directed at any target * Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma * Active or history of plasma cell leukemia at the time of screening * Seropositive for human immunodeficiency virus (HIV) * Active Hepatitis B infection * Active Hepatitis C infection * Serious underlying medical condition

Primary outcome measure(s)

  • Adverse Events (AEs) — 2 years
    Incidence and severity of adverse events (AEs)
  • Serious Adverse Events (SAEs) — 2 years
    Incidence and severity of serious adverse events (SAEs)
  • Dose Limiting Toxicities (DLT) — 28 days
    Incidence of dose limiting toxicities events

Trial sites (13)

FacilityCityRegionStatus
Research Site Phoenix Arizona Withdrawn
Research Site Duarte California Recruiting
Research Site Denver Colorado Recruiting
Research Site Tampa Florida Active Not Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Iowa City Iowa Recruiting
Research Site Rochester Minnesota Withdrawn
Research Site St Louis Missouri Recruiting
Research Site New York New York Recruiting
Research Site Nashville Tennessee Recruiting
Research Site Dallas Texas Withdrawn
Research Site Houston Texas Recruiting
Research Site Charlottesville Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073547 on ClinicalTrials.gov ↗ ← All trials in the USA