NCT06983964

Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases

Exploratory Clinical Study Evaluating the Safety and Efficacy of Universal CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.

Conditions

• Autoimmune Disease

Interventions

Type	Name	Description
GENETIC	CD19 CART	Dose group dosage unit (CAR+T cells/kg) Acceptable dose range Expected sample size (± 30%, CAR+T cells/kg) 1. 0.5 × 106 0.4 × 106\~0.6 × 106 3-6 cases 2. 1.0 × 106 0.7 × 106\~1.3 × 106 3-6 cases 3. 2.0 × 106 1.4 × 106\~2.6 × 106 3-6 cases Dose escalation rule The enrollment starts from dose group 1, and if no DLT occurs in the 3 subjects included, they will be transferred to the next dose group. If one of the three subjects in a certain dose group develops DLT, three additional subjects will be added to the group for cell infusion at the same dose. If there is ≥ 1 case of DLT in the 3 additional cases, it will be reduced to the previous dose group. If there are only 3 subjects in the previous dose group at this time, an additional 3 subjects need to be added for the trial; If there are already 6 subjects in the previous dose group, the trial ends and this dose is the maximum tolerated dose (MTD).

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-02-20
• Completion: 2027-09-30
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: China