Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

May 30, 2026

Conditions
Difficult to Treat Systemic Lupus Erythematosus
Interventions
BIOLOGICAL

Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells

"About 6 subjects will be included in the study, and a 3+3 dose escalation method will be used. The dosage will be gradually increased in two dose groups: 1 × 10 \^ 8 CAR-T cells/dose and 2 × 10 \^ 8 CAR-T cells/dose. Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study."

All Listed Sponsors
lead

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY