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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2027-12-20

Brief Summary

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

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus (SLE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR-T treatment

Group Type EXPERIMENTAL

CAR-T cell

Intervention Type DRUG

CAR-T cell

Interventions

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CAR-T cell

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No