NCT07155369

UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.

Conditions

• Systemic Lupus Erythematosus
• Systemic Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	UCAR-T cells	UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered intravenously.
DRUG	Fludarabine	Fludarabine will be administered intravenously.

Timeline

• Start date: 2025-03-18
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China