AZD0120 treatment for adults with newly diagnosed or early relapsed multiple myeloma.

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)

This study will try AZD0120 in adults with newly diagnosed, early relapsed, or primary refractory multiple myeloma to see if it is safe and shows early signs of benefit.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: CAR T
• Locations: 13 sites (Phoenix, Arizona and 12 other locations)
• Trial ID: NCT07073547 on ClinicalTrials.gov

What this trial studies

This is an open-label, modular Phase 1 multicenter study testing AZD0120 in adults with newly diagnosed, early relapsed, or primary refractory multiple myeloma. The trial focuses primarily on safety and tolerability and also measures cellular kinetics, pharmacodynamics, immunogenicity, and preliminary efficacy. There are separate modules for newly diagnosed patients (including options with AZD0120 ± maintenance) and for patients with early relapsed or primary refractory disease after one or two prior therapies. Eligible participants must meet IMWG diagnostic criteria, have ECOG 0–1, and adequate organ and marrow function.

Who should consider this trial

Good fit: Adults (≥18 years) with multiple myeloma per IMWG criteria, ECOG 0–1, adequate organ and marrow function, and either high-risk newly diagnosed disease or early relapsed/primary refractory disease after 1–2 prior lines (including a PI and IMiD) are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, or those who are heavily pretreated beyond two prior lines are less likely to benefit from participation.

Why it matters

Potential benefit: If successful, AZD0120 could provide a new cellular therapy option that controls disease and delays progression in high-risk newly diagnosed or early-relapsed multiple myeloma.

How similar studies have performed: Other BCMA-directed CAR-T therapies have shown high response rates in relapsed/refractory multiple myeloma, so this approach builds on promising but still early clinical experience.

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

Where this trial is running

Phoenix, Arizona and 12 other locations

• 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 (Recruiting)
• Research Site — Atlanta, Georgia, United States (Recruiting)
• Research Site — Iowa City, Iowa, United States (Not_yet_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)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Multiple Myeloma; Multiple myeloma; BCMA; CD19; CAR-T