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

NCT07652138 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital of Soochow University

Phase

Phase 1

Started

2025-07-30

Last updated

2026-06-16

Condition(s) studied

Multiple MylomaNewly Diagnosed Multiple Myeloma (NDMM)

Investigational drug(s) / intervention(s)

BCMA/CD19-targeted allogeneic CAR-T →

BCMA/CD19-targeted allogeneic CAR-T: Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs) — DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	Recruiting

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Other trials for the same condition

RN1201 Injection in Newly Diagnosed High-Risk Cytogenetic Multiple Myeloma Starting soon

A Phase III, Multicentre Study to Evaluate Consolidation Treatment With AZD0120 Compared With ASCT, in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible (DURGA-6). Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07652138 on ClinicalTrials.gov ↗ ← All trials in China