NCT07052565

CAR-T Cells Therapy for Patients With Autoimmune Diseases

An Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART

Detailed description

This study is a single-center, single-arm, non-blinded, 3+3 dose-escalation designed investigator initiated trial study, evaluating the safety, efficacy, and therapeutic assessment of ECAR01 injection in patients with refractory autoimmune diseases. The specific research protocol can be adjusted by the researchers based on the patient's condition. Patients with refractory autoimmune diseases who meet the inclusion and exclusion criteria are included. After peripheral blood collection and chemotherapy pretreatment, the subjects undergo CAR-T cell infusion. The three dose groups are the low-dose group (1×10\^5/kg, number of CAR-T cells per kg of subject's weight, the same below), the medium-dose group (3×10\^5/kg), and the high-dose group (6×10\^5/kg). Clinicians can also adjust the drug dose based on actual conditions. Given the particularity of cell preparation doses, each dose group allows for a ±20% fluctuation in the actual drug dose.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis	A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg）

Timeline

• Start date: 2025-07-20
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-07-04
• Last updated: 2025-07-08

Locations

1 site across 1 country: China