AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

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.

Conditions2

Interventions2

Locations36 sites

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• A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2) — AstraZeneca
• A Study of AZD0120 in Autoimmune Diseases — AstraZeneca
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