Back to Trials
NCT05850234PHASE1, PHASE2Recruiting

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

AstraZeneca

Start Date

7/20/2023

Completion Date

11/14/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥18 years of age at the time of consent. * ECOG performance status of 0 or 1. * Documented diagnosis of MM per IMWG diagnostic criteria. * Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. * Have documented evidence of progressive disease per IMWG criteria. * Participant must have measurable disease at screening. * Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening. Exclusion Criteria : * Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy. * Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply. * Participant has significant cardiac, neurological, or psychiatric conditions. * Any other significant medical conditions such as: * Serious active or uncontrolled infection * Active autoimmune disease or a history of autoimmune disease within 2 years * Active plasma cell leukemia at the time of screening * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF). * Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM. Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

BIOLOGICAL

AZD0120

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Relapsed/Refractory Multiple Myeloma

Locations

Research Site

Birmingham, Alabama 35233

United States

Research Site

Phoenix, Arizona 85054

United States

Research Site

La Jolla, California 92037

United States

Research Site

Los Angeles, California 90095

United States

Research Site

San Francisco, California 94143

United States

Research Site

Aurora, Colorado 80045

United States

Research Site

Denver, Colorado 80218

United States

Research Site

Jacksonville, Florida 32224

United States

Research Site

Miami, Florida 33136

United States

Research Site

Tampa, Florida 33612

United States

Research Site

Atlanta, Georgia 30322

United States

Research Site

Chicago, Illinois 60637

United States

Research Site

Iowa City, Iowa 52242

United States

Research Site

Boston, Massachusetts 02114

United States

Research Site

Boston, Massachusetts 02215

United States

Research Site

Ann Arbor, Michigan 48109

United States

Research Site

Detroit, Michigan 48202

United States

Research Site

Minneapolis, Minnesota 55455

United States

Research Site

Rochester, Minnesota 55905

United States

Research Site

Omaha, Nebraska 68198

United States

Research Site

Hackensack, New Jersey 07601

United States

Research Site

Buffalo, New York 14203

United States

Research Site

New York, New York 10065

United States

Research Site

Stony Brook, New York 11794

United States

Research Site

Charlotte, North Carolina 28204

United States

Research Site

Durham, North Carolina 27705

United States

Research Site

Nashville, Tennessee 37203

United States

Research Site

Nashville, Tennessee 37232

United States

Research Site

Austin, Texas 78704

United States

Research Site

Dallas, Texas 75390

United States

Research Site

Houston, Texas 77030

United States

Research Site

Salt Lake City, Utah 84112

United States

Research Site

Charlottesville, Virginia 22908

United States

Research Site

Edmonds, Washington 98026

United States

Research Site

Seattle, Washington 98109

United States

Research Site

Milwaukee, Wisconsin 53226

United States