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NCT07073547From ClinicalTrials.govRecruiting

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)

  • Multiple Myeloma

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AstraZeneca
Enrolment target
40
Started
31 July 2025
Main results due
26 May 2028
Study sites
13
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(13)

  • Research Site

    Phoenix, Arizona, United States

    Withdrawn

  • Research Site

    Duarte, California, United States

    Recruiting

  • Research Site

    Denver, Colorado, United States

    Recruiting

  • Research Site

    Tampa, Florida, United States

    Active, not recruiting

  • Research Site

    Atlanta, Georgia, United States

    Recruiting

  • Research Site

    Iowa City, Iowa, United States

    Recruiting

  • Research Site

    Rochester, Minnesota, United States

    Withdrawn

  • Research Site

    St Louis, Missouri, United States

    Recruiting

  • Research Site

    New York, New York, United States

    Recruiting

  • Research Site

    Nashville, Tennessee, United States

    Recruiting

  • Research Site

    Dallas, Texas, United States

    Withdrawn

  • Research Site

    Houston, Texas, United States

    Recruiting

  • Research Site

    Charlottesville, Virginia, United States

    Recruiting

Showing 13 of 13 sites. 9 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07073547. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenici | Trialion