NCT06852573

Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus

A Phase I Clinical Study to Evaluate the Safety and Efficacy of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus

Detailed description

This study is planned to enroll 12-30 patients with refractory SLE in a dose-escalation "3+3" design with 4 dose groups, 2.5×10\^7 CAR-T cells, 5×10\^7 CAR-T cells, 1×10\^8 CAR-T cells and 2×10\^8 CAR-T cells. Each dose group is planned to enroll 3-6 subjects to evaluate its safety. -T cells. 3-6 subjects are planned to be enrolled in each dose group to assess safety, and if subjects in a dose group have a horizontal dose-limiting toxicity (DLT) incidence of≤ 1/6 within 28 days of infusing back, cell infusing back into the next dose group of subjects may be initiated. One or two dose groups will be selected to enroll additional subjects in the study for the extension phase based on the opinion of the Drug Safety Monitoring Board, and 3-6 additional subjects are proposed to be enrolled in each selected dose group for further evaluation of safety and efficacy. This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	ZM001 Injection	ZM001 injection, 2.5× 10\^7 CAR-T cells, 5× 10\^7 CAR-T cells, 1× 10\^8 CAR-T cells and 2× 10\^8 CAR-T cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 30 mg/m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 300 mg/ m\^2 (D-5\~D-3), determined by tumor burden at baseline.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-02-20
• Completion: 2027-08-20
• First posted: 2025-02-28
• Last updated: 2025-02-28