A Study of GC012F, a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
- Conditions
- Relapsed/ Refractory Multiple Myeloma
- Registration Number
- NCT05850234
- Lead Sponsor
- Gracell Biopharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Males and females =18 years of age at the time of consent<br><br> - Written informed consent in accordance with federal, local, and institutional<br> guidelines<br><br> - Have an ECOG performance status of 0 or 1<br><br> - Documented diagnosis of MM per IMWG diagnostic criteria<br><br> - Received at least three prior MM treatment lines of therapy<br><br> - Have received as part of their previous therapy a PI and IMiD and an antiCD38<br> antibody.<br><br> - Have documented evidence of progressive disease by the IMWG criteria.<br><br> - Subjects must have measurable disease at screening, as defined by any of the<br> following: serum monoclonal paraprotein (M-protein) =1.0g/dL (10 g/L); urine<br> M-protein =200 mg/24 h; serum FLC assay: involved FLC level is =10 mg/dL (100 mg/L)<br> and serum kappa lambda FLC ratio is abnormal.<br><br> - Adequate bone marrow and organ function assessment at screening according to the<br> hematological, hepatic, and renal parameters listed in the CSP<br><br>Exclusion Criteria :<br><br>• Diagnosed or treated for invasive malignancy other than multiple myeloma, except:<br>Malignancy treated with curative intent and with no known active disease present for =2<br>years before enrollment; or<br><br> - Adequately treated non-melanoma skin cancer without evidence of disease.<br><br> - The following cardiac conditions:<br><br> - New York Heart Association (NYHA) stage III or IV congestive heart failure<br><br> - Myocardial infarction or coronary artery bypass graft (CABG) =6 months prior to<br> enrollment<br><br> - History of clinically significant ventricular arrhythmia or unexplained<br> syncope, not believed to be vasovagal in nature or due to dehydration<br><br> - History of severe non-ischemic cardiomyopathy<br><br> - Received either of the following:<br><br> - An allogenic stem cell transplant within 6 months before apheresis. Subjects<br> who received an allogeneic transplant must be off all immunosuppressive<br> medications for 6 weeks without signs of graft-versus-host disease (GVHD).<br><br> - An autologous stem cell transplant =12 weeks before apheresis<br><br> - Known active, or prior history of central nervous system (CNS) involvement or<br> exhibits clinical signs of meningeal involvement of multiple myeloma.<br><br> - Plasma cell leukemia at the time of screening (>2.0×109 /L plasma cells by standard<br> differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy,<br> organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL<br> amyloidosis.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1b Adverse Events (AEs);Phase 1b Dose-limiting toxicities;Phase 2 Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method Phase 1b Pharmacokinetic - AUC;Phase 1b Pharmacokinetic - Cmax;Phase 1b Pharmacokinetic - half-life;Phase 1b Pharmacokinetic - Tmax;Phase 2: Adverse Events (AEs);Phase 1b and 2: Overall Response Rate (ORR);Phase 1b and 2: MRD negative rate;Phase 1b and 2: Duration of response (DOR);Phase 1b and 2: PFS;Phase 1b and 2: OS