AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
AstraZeneca
182 participants
Jul 20, 2023
INTERVENTIONAL
Conditions
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 Criteria7
- ≥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 Criteria9
- 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.
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Interventions
AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.
Locations(36)
View Full Details on ClinicalTrials.gov
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NCT05850234