RecruitingPhase 1Phase 2NCT05850234
A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
A Phase 1b/2 Study of GC012F (AZD0120), a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma
Sponsor
AstraZeneca
Enrollment
80 participants
Start Date
Jul 20, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- Males and females ≥18 years of age at the time of consent
- 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 Criteria12
- Diagnosed or treated for invasive malignancy other than multiple myeloma, except: Malignancy treated with curative intent and with no known active disease present for ≥2 years before enrollment; or
- 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.
Interventions
BIOLOGICALGC012F (AZD0120)
GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.
Locations(37)
View Full Details on ClinicalTrials.gov
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NCT05850234
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