Clinical Trials in the USA / NCT05850234
Recruiting
Phase 1/2
AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
NCT05850234 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Relapsed/Refractory Multiple Myeloma
Investigational drug(s) / intervention(s)
AZD0120: AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Phase 1b: Adverse Events (AEs) — Through study completion, a minimum of 2 years.
The incidence and severity of AEs. - Phase 1b: Dose-Limiting Toxicities (DLTs) — 28 days
The DLT evaluation period is defined as the first 28 days after infusion. - Phase 2: Objective Response Rate (ORR) — Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Birmingham | Alabama | Recruiting |
| Research Site | Phoenix | Arizona | Recruiting |
| Research Site | La Jolla | California | Recruiting |
| Research Site | Los Angeles | California | Recruiting |
| Research Site | San Francisco | California | Recruiting |
| Research Site | Aurora | Colorado | Recruiting |
| Research Site | Denver | Colorado | Recruiting |
| Research Site | Jacksonville | Florida | Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Tampa | Florida | Recruiting |
| Research Site | Atlanta | Georgia | Recruiting |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Iowa City | Iowa | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Boston | Massachusetts | Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | Detroit | Michigan | Recruiting |
| Research Site | Minneapolis | Minnesota | Recruiting |
| Research Site | Rochester | Minnesota | Recruiting |
| Research Site | Omaha | Nebraska | Withdrawn |
| Research Site | Hackensack | New Jersey | Withdrawn |
| Research Site | Buffalo | New York | Withdrawn |
| Research Site | New York | New York | Recruiting |
| Research Site | Stony Brook | New York | Recruiting |
| Research Site | Charlotte | North Carolina | Recruiting |
| Research Site | Durham | North Carolina | Recruiting |
| Research Site | Nashville | Tennessee | Recruiting |
| Research Site | Nashville | Tennessee | Recruiting |
| Research Site | Austin | Texas | Recruiting |
| Research Site | Dallas | Texas | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Salt Lake City | Utah | Recruiting |
| Research Site | Charlottesville | Virginia | Recruiting |
| Research Site | Edmonds | Washington | Recruiting |
| Research Site | Seattle | Washington | Recruiting |
| Research Site | Milwaukee | Wisconsin | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05850234 on ClinicalTrials.gov ↗ ← All trials in the USA