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

July 15, 2025 updated by: Qiubai Li, Wuhan Union Hospital, China

A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Systemic Lupus Erythematosus (SLE)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Wuhan Union Hospital
        • Contact:
        • Principal Investigator:
          • Qiubai Li, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T treatment
Drug: CAR-T cell
CAR-T cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: 0~28 day after treatment
0~28 day after treatment
Frequency of AEs, SAEs
Time Frame: 0 day to 24 months after treatment
0 day to 24 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 10, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

July 17, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AID04-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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