drugset / Trial / NCT07105735
RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies
Phase 1
Not yet recruiting
18 enrolled
The First Affiliated Hospital with Nanjing Medical University
Allorunning Therapeutics · collabRui Therapeutics Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a open-label, exploratory trial to evaluate the safety, feasibility, and preliminary efficacy of RN1201, an Allogeneic CAR-T cell therapy, in patients with autoimmune diseases refractory to standard treatment. Eligible patients with moderate to severe activity of diseases will receive a single infusion of RN1201 following lymphodepletion. Primary endpoints include dose-limiting toxicity and treatment-emergent adverse events. Secondary and exploratory endpoints assess clinical response and cell pharmacokinetics.
Timeline
- Start
- 2025-08
- Primary completion
- 2027-08
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RN1201 | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
Indications
No indication recorded.