NCT07652138
Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
RecruitingPHASE1
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.
At a glance
- Conditions
- Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM)
- Interventions
- BCMA/CD19-targeted allogeneic CAR-T
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Target enrollment
- 18 participants
- Age
- 18 Years – 70 Years
- Sex
- ALL
- Locations
- The First Affiliated Hospital of Soochow University
- Registry
- View on ClinicalTrials.gov ↗
Eligibility criteria
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.