NCT07444307

A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus

A Phase I/IIa Clinical Study to Evaluate Universal Allogeneic CAR-T Cells (QT-019B) Targeting CD19 and BCMA for the Treatment of Refractory Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hangzhou Qihan Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD. The study has two phases: dose escalation and dose expansion, with a planned enrollment of 18-24 subjects.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	QT-019B Cell Injection	The study will begin by enrolling the first subject in Dose A (1×106/kg), followed by a 14-day interval before enrolling the following subjects at this dose level. Upon completing the DLT observation period for Dose Group A: 1) if no DLTs are observed, the SRC may choose to proceed to Dose Group B (3×106/kg). 2) if one DLT is noted, the SRC may opt to add 3 more subjects to Dose A, and if a second DLT occurs, the SRC may consider ending the study or reducing the dose. 3) if two DLTs are observed at Dose A, the SRC may decide to terminate the study or reduce the dose.

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

3 sites across 1 country: China