A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
Age: 18 years - 66+
Healthy Subjects: No
Study Phase: Phase 1/Phase 2
Recruitment Status: Recruiting
Start Date: July 20, 2023
End Date: June 01, 2026
- 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.
- Adequate bone marrow and organ function
- 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.