A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma
Trial Parameters
Brief Summary
This study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.
Eligibility Criteria
Inclusion Criteria: 1. Patients must have a diagnosis of active multiple myeloma as defined by the updated IMWG (International Myeloma Working Group) criteria, and meet one or more of the following criteria: 1. Serum M protein ≥ 1 g/dL； 2. Urine M protein ≥ 200 mg/24hrs; 3. Serum free light chain (sFLC) ≥ 10 mg/dL with abnormal sFLC κ/λ ratio. 2. Have received at least 3 prior lines of therapy for multiple myeloma. Note: According to IMWG guidelines, a single line of therapy includes a full course of monotherapy, combination therapy with multiple drugs, or sequential treatment with multiple regimens (e.g., the use of a 3-6 cycle regimen of bortezomib combined with dexamethasone, followed by stem cell transplantation, consolidation therapy, and lenalidomide maintenance therapy, is considered a single line of therapy). Unless the best response was documented as progressive disease (PD) or the subject was intolerant to the therapy. 3. Prior therapy should include proteasome inhibitors (PI