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 AZD0120

What's the purpose of this trial?

This trial is a phase 1, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CAR T-cell therapy, in early-line treatment in subjects with Multiple Myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

Age:

  • Males and females ≥18 years of age at the time of consent

Type of Participant and Disease Characteristics:

  • Participant must have documented diagnosis of MM per IMWG diagnostic criteria
  • ECOG performance status of 0 or 1.
  • Adequate organ and bone marrow function.

For NDMM participants:

  • Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
  • For participants on Module 2: Newly diagnosed MM with a maximum of 6 cycles and minimum of 4 cycles of induction therapy completed prior to screening
  • Classified as high-risk MM

For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:

  • Have received and failed 1 or 2 lines of anti-myeloma therapy
  • Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
  • Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen

General Exclusion Criteria:

  • Have received prior treatment with CAR T therapy directed at any target
  • Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
  • Active or history of plasma cell leukemia at the time of screening
  • Seropositive for human immunodeficiency virus (HIV)
  • Active Hepatitis B infection
  • Active Hepatitis C infection
  • Serious underlying medical condition

Additional Trial Information

Phase 1

Enrollment: 64 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Florida

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New York

New York University Langone Medical Center Laura and Isaac Perlmutter Cancer Center

New York, NY

Open and Accepting

Tennessee

Tennessee Oncology - Hayes

Nashville, TN

Open and Accepting
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