This is a single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of RN9101 injection for patients with relapsed/refractory multiple myeloma.
Age ≥18 years, either sex;
Diagnosis of multiple myeloma (MM) according to IMWG response criteria, with BCMA target antigen expression on MM cells confirmed by flow cytometry or bone marrow pathology and immunohistochemistry;
Received at least 2 prior lines of anti-multiple myeloma therapy, with each line containing at least one complete treatment cycle, and documented disease progression during or after the most recent anti-myeloma therapy based on assessment data;
Serum M-protein ≥ 0.5 g/dL;
Received targeted therapy, epigenetic therapy, other investigational drug therapy, or treatment involving invasive investigational medical devices within 5 half-lives;
Received systemic immunologic or non-immunologic therapy within 1 week;
Received cytotoxic therapy within 1 week;
Received proteasome inhibitor and immunomodulatory therapy within 2 weeks;