A Study of CAR-T Cells in Subjects with Systemic Lupus Erythematosus

Not Applicable

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: CAR-T cell

• Registration Number: NCT06900764
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-10
• Primary Completion: 2027-10-15
• Study Completion: 2027-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male or female, between 18 and 65 years old;
• Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
• Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
• SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
• Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
• Good organ functions;
• Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria

• Had or has active malignancy;
• Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
• Combined with other autoimmune disease that needs treatment;
• Pregnant or lactating women;
• Has other factors that deemed not suitable by investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T treatment	CAR-T cell	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	0~28 day after treatment
Frequency of AEs, SAEs	0 day to 24 months after treatment

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China