Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Anupama Kumar

Description

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.

Official Title

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)

Details

Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple myeloma and determine the recommended Phase 2 dose of AZD0120.

Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of life parameters in subjects with relapsed/refractory multiple myeloma.

Keywords

Relapsed/Refractory Multiple Myeloma, Multiple Myeloma, BCMA, CAR T, CD19, AZD0120, Multiple Myeloma, AZD0120

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥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.

You CAN'T join if...

:

  • 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.

Locations

  • Research Site accepting new patients
    San Francisco California 94143 United States
  • Research Site accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSF

  • Anupama Kumar
    Dr. Kumar is hematologist/oncologist who specializes in taking care of patients with hematological malignancies. She completed medical school training and residency at Tufts Medical Center, and hematology/oncology fellowship at University of California, San Diego. She received specialized training through the bone marrow transplant track during her final year of fellowship.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05850234
Phase
Phase 1/2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 182 study participants
Last Updated