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
Hangzhou Qihan Biotech Co., Ltd.
18 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07444307