AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
Purpose
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.
Condition
- Relapsed/Refractory Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- AZD0120 will be administered by infusion
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AZD0120 |
AZD0120 will be administered by infusion |
|
Recruiting Locations
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.