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

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.

Study Overview

• Status: Recruiting
• Conditions: Newly Diagnosed Multiple Myeloma (NDMM); Multiple Myloma
• Intervention / Treatment: Drug: BCMA/CD19-targeted allogeneic CAR-T

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaowen Tang; Phone Number: 13913538266; Email: tangxiaowen@suda.edu.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Xiaowen Tang; Phone Number: 13913538266; Email: tangxiaowen@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allogeneic CAR-T cell therapy; Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy	Drug: BCMA/CD19-targeted allogeneic CAR-T; Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall effectiveness and duration of efficacy	Overall response rate (ORR) and complete response rate (CR), negative rate of MRD (detected by flow cytometry or NGS)	4 weeks, 3 months, 6 months, and 12 months
Pharmacokinetic (PK) of RN1201	Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow	Up to 52 weeks
Pharmacodynamic (PD) of RN1201	Levels of Peripheral blood M protein	Up to 52 weeks
Pharmacodynamic (PD) of RN1201	Levels of urine M protein	Up to 52 weeks
Pharmacodynamic (PD) of RN1201	Levels of Peripheral blood cytokines	Up to 52 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No