AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
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.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05850234.
Locations matching your search criteria
United States
Alabama
Birmingham
Arizona
Scottsdale
California
Duarte
La Jolla
Los Angeles
San Francisco
Colorado
Aurora
Florida
Jacksonville
Tampa
Georgia
Atlanta
Illinois
Chicago
Iowa
Iowa City
Massachusetts
Boston
Michigan
Ann Arbor
Minnesota
Rochester
New York
New York
North Carolina
Charlotte
Durham
Texas
Dallas
Houston
Virginia
Charlottesville
Washington
Seattle
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.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationAstraZeneca Pharmaceuticals LP
- Primary IDD8310C00001
- Secondary IDsNCI-2023-06014, GC012F-CD19/BCMA-001
- ClinicalTrials.gov IDNCT05850234