An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
• Willingness to participate in the trial and provide written informed consent.
‣ 2\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
⁃ 3\. BCMA-positive multiple myeloma documented at screening or in prior medical records.
⁃ 4\. Aged 18 - 70 years, any gender.
⁃ 5\. Life expectancy of at least 12 weeks.
⁃ 6\. Serum total bilirubin \< twice the upper limit of normal (ULN); serum creatinine within normal range;
⁃ 7\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times ULN.
⁃ 8\. ECOG performance status score of 0 - 2.
⁃ 9\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.
⁃ 10\. Ability to adhere to the study visit schedule and protocol requirements.