RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies

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.

NCT Number	NCT07105735
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University Collaborators: Rui Therapeutics Co., Ltd, Allorunning Therapeutics
Conditions	Autoimmune Diseases Refractory to Standard Therapies
Enrollment	18 participants
Start Date	2025-08
Primary Completion	2027-08 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-06