Overview

This trial is a phase 1b/2, open-label, multicenter study of GC012F, a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.

Eligibility

Inclusion Criteria:

• 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 Criteria :

        • 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.