NCT07652138RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 30 Jul 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Multiple myeloma
- NCT number
- NCT07652138
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 30 Jul 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.