A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Trial Parameters
Brief Summary
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria * Relapsed/refractory multiple myeloma as defined by: 1\) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD, and an anti-CD38 antibody). 2）Disease progression within 12 months of the most recent anti-MM therapy; or disease progression within the past 6 months and subsequently lack response to the most recent line of therapy. * Measurable disease at screening as defined by any of the following: 1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or 2. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D expression positive if previously received BCMA targeted therapy