A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
NCT ID: NCT05850234
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2023-07-20
2028-11-15
Brief Summary
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Detailed Description
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For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GC012F (AZD0120)
GC012F (AZD0120) will be administrated in one infusion
GC012F (AZD0120)
GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.
Interventions
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GC012F (AZD0120)
GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent in accordance with federal, local, and institutional guidelines
* Have an ECOG performance status of 0 or 1
* Documented diagnosis of MM per IMWG diagnostic criteria
* Received at least three prior MM treatment lines of therapy
* Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.
* Have documented evidence of progressive disease by the IMWG criteria.
* Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.
* Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP
Exclusion Criteria
* Adequately treated non-melanoma skin cancer without evidence of disease.
* The following cardiac conditions:
* New York Heart Association (NYHA) stage III or IV congestive heart failure
* Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
* History of severe non-ischemic cardiomyopathy
* Received either of the following:
* An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).
* An autologous stem cell transplant ≤12 weeks before apheresis
* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
* Plasma cell leukemia at the time of screening (\>2.0×109 /L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Iowa City, Iowa, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Hackensack, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Stony Brook, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
Research Site
Edmonds, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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GC012F-CD19/BCMA-001
Identifier Type: OTHER
Identifier Source: secondary_id
D8310C00001
Identifier Type: -
Identifier Source: org_study_id
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