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;
Single group
RN9101 injection
DrugPatients will receive a single intravenous infusion of RN9101 injection
Dose-limiting toxicities (DLTs)
Dose limiting toxicity will be assessed after injection
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) would be graded according to the ASTCT consensus
immune cell-associated neurotoxicity syndrome (ICANS)
ICANS would be scored according to Immune Effector Cell-Associated Encephalopathy (ICE), and then graded by the ASTCT consensus.
Treatment-associated adverse effects (AEs)
All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Objective Response Rate (ORR)
The responses will be assessed by IWG criteria
Disease control rate (DCR)
The responses will be assessed by IWG criteria
Pharmacokinetic (PK) of RN9101
CAR-T kinetics would be detected by flow cytometry and digital PCR in peripheral blood and bone marrow at each important time points. Cmax is the peak expansion value of CAR-T cells.
Pharmacodynamic (PD) of RN9101
Levels of B cells in peripheral blood as cells/ul.
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