A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
Purpose
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.
Condition
- Relapsed/ Refractory Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- GC012F will be administrated in one infusion
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental GC012F |
GC012F will be administrated in one infusion |
|
Recruiting Locations
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Gracell Biopharmaceuticals, Inc.
Detailed Description
For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F. For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F, 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.