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

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Drug: CAR-T cell

Study type: Interventional

Funder types: Other

Identifiers

NCT06900764

AID04-01

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CAR-T treatment

Experimental group

Treatment:

Drug: CAR-T cell