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

NCT06900764 | Not Yet Recruiting

• 1 other identifier: AID04-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

SLE; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicity

  0~28 day after treatment

• Frequency of AEs, SAEs

  0 day to 24 months after treatment

Study Arms (1)

CAR-T treatment

EXPERIMENTAL

Drug: CAR-T cell

Interventions

CAR-T cell DRUG

CAR-T cell

CAR-T treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Qiubai Li, MD/PhD

CONTACT

+86 (027)85726808; qiubaili@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Rheumatology and Immunology

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)