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Recruiting NCT07652138

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

Phase I Interventional Multiple Myloma Newly Diagnosed Multiple Myeloma (NDMM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BCMA/CD19-targeted allogeneic CAR-T.
Who it may be relevant to
Registry conditions: Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs) [Time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.]
Secondary outcome measures (5)
  • Overall effectiveness and duration of efficacy [Time frame: 4 weeks, 3 months, 6 months, and 12 months]
  • Pharmacokinetic (PK) of RN1201 [Time frame: Up to 52 weeks]
  • Pharmacodynamic (PD) of RN1201 [Time frame: Up to 52 weeks]
  • Pharmacodynamic (PD) of RN1201 [Time frame: Up to 52 weeks]
  • Pharmacodynamic (PD) of RN1201 [Time frame: Up to 52 weeks]

Eligibility criteria

Inclusion criteria

  • 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

  • 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:
  • Resected non-melanoma (e.g., basal cell carcinoma)
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07652138 · 2025510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗