NCT06513429

IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)

Clinical Study on Evaluating the Efficacy and Safety of IM19 CAR-T Cell Therapy in Patients With Refractory Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg or 1×10\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.

Conditions

• Refractory Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	IM19 CAR-T cells	IM19 CAR-T cells by intravenous infusion.

Timeline

• Start date: 2024-07-30
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-07-22
• Last updated: 2025-08-17

Locations

1 site across 1 country: China