Overview

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.

Eligibility

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. Patients with serious active infections.
   • 2\. Subjects with acquired or congenital immunodeficiency.
   • 3\. Subjects with Class III/IV heart failure per NYHA criteria.
   • 4\. Subjects with epilepsy or other central nervous system diseases.
   • 5\. Subjects with a history of primary cancer, except:
     1. Resected non-melanoma (e.g., basal cell carcinoma)
     2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)
   • 6\. Systemic high-dose steroid use within 2 weeks before treatment.
   • 7\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.
   • 8\. Participation in other clinical trials within one month.
   • 9\. Major surgery within 14 days before the first study drug dose.
   • 10\. Any condition the investigator deems may raise subject risks or affect trial results.