AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
United States182 participantsStarted 2023-07-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 inv…
What they're measuring
1
Phase 1b: Adverse Events (AEs)
Timeframe: Through study completion, a minimum of 2 years.
2
Phase 1b: Dose-Limiting Toxicities (DLTs)
Timeframe: 28 days
3
Phase 2: Objective Response Rate (ORR)
Timeframe: Through study completion, a minimum of 2 years.