Winship Logo

Clinical Trial Details

Back to clinical trials
Phase I/IIInterventional

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)

Protocol: STUDY00009087NCT: NCT05850234

Overview

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

Ages18 Years and older
SexAll
Healthy VolunteersNo
Age GroupsAdult, Older Adult

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.

Investigators
Locations
Emory University Hospital Midtown
Winship Cancer Institute
View on ClinicalTrials.gov