RN1201 donor-cell therapy as first treatment for newly diagnosed multiple myeloma
Tests RN1201, an immune cell therapy, in adults newly diagnosed with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07652138, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT07652138
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.