NCT06892145

Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE

Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.

Detailed description

Based on the specific CD19-targeting CAR-T developed by PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs.At the same time, MC-1-50 products contain a high proportion of T naive cells, which can play a therapeutic role at a very low infusion dose and improve safety. In this study, three dose groups were composed of 0.3×10\^5/kg, 1×10\^5/kg and 3×10\^5/kg CAR-positive cells, respectively.All subjects received only one infusion of MC-1-50 cells.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Refractory

Interventions

Type	Name	Description
BIOLOGICAL	MC-1-50	A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-05-04
• Completion: 2028-02-16
• First posted: 2025-03-24
• Last updated: 2025-12-22

Locations

2 sites across 1 country: China