RecruitingPhase 1NCT07652138

Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

18 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Multiple Myeloma (NDMM)Multiple Myloma

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria10

Willingness to participate in the trial and provide written informed consent.
\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
\. BCMA-positive multiple myeloma documented at screening or in prior medical records.
\. Aged 18 - 70 years, any gender.
\. Life expectancy of at least 12 weeks.
\. Serum total bilirubin < twice the upper limit of normal (ULN); serum creatinine within normal range;
\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times ULN.
\. ECOG performance status score of 0 - 2.
\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.
\. Ability to adhere to the study visit schedule and protocol requirements.

Exclusion Criteria12

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