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

NCT07652138 | Recruiting Phase 1

• 1 other identifier: 2025510
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myloma; Newly Diagnosed Multiple Myeloma (NDMM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall effectiveness and duration of efficacy

  4 weeks, 3 months, 6 months, and 12 months

• Pharmacokinetic (PK) of RN1201

  Up to 52 weeks

• Pharmacodynamic (PD) of RN1201

  Up to 52 weeks

• Pharmacodynamic (PD) of RN1201

  Up to 52 weeks

• Pharmacodynamic (PD) of RN1201

  Up to 52 weeks

Study Arms (1)

Allogeneic CAR-T cell therapy

EXPERIMENTAL

Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy

Drug: BCMA/CD19-targeted allogeneic CAR-T

Interventions

BCMA/CD19-targeted allogeneic CAR-T DRUG

Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion

Allogeneic CAR-T cell therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Central Study Contacts

Xiaowen Tang

CONTACT

13913538266; tangxiaowen@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: July 30, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)