NCT05850234 AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
| NCT ID | NCT05850234 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AstraZeneca |
| Condition | Relapsed/Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2023-07-20 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 232 participants in total. It began in 2023-07-20 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05850234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05850234 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05850234 currently recruiting?
Yes, NCT05850234 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT05850234 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, La Jolla, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT05850234 clinical trial?
NCT05850234 is sponsored by AstraZeneca. The trial plans to enroll 232 participants.