Clinical Research Directory
Browse clinical research sites, groups, and studies.
RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies
Sponsor: The First Affiliated Hospital with Nanjing Medical University
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.
Official title: An Exploratory Clinical Study on Allogeneic CAR-T Cell (RN1201) Injection for Autoimmune Diseases Refractory to Standard Therapies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2025-08
Completion Date
2027-12
Last Updated
2025-08-06
Healthy Volunteers
No
Interventions
allogeneic CAR-T
Fludarabine injection (30 mg/m2,QD×3d) and cyclophosphamide injection (300 mg/m2,QD×3d)will be used to remove the lymphocyte before RN1201 infusion.
Locations (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China