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Not yet recruitingNCT06900764Updated Jul 17, 2025

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

An interventional study of CAR-T cell in Systemic Lupus Erythematosus (SLE), sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Systemic Lupus Erythematosus (SLE)

Keywords

  • SLE
  • Systemic Lupus Erythematosus
03

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    CAR-T treatment

    Drug: CAR-T cell

Interventions

  • DrugCAR-T cell

    CAR-T cell

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity

    Time frame: 0~28 day after treatment

  2. Frequency of AEs, SAEs

    Time frame: 0 day to 24 months after treatment

07

Study locations

1 site
  • Wuhan Union Hospital
    Wuhan, Hubei 430000, China
    • Qiubai Li, MD/PhD · Contact · qiubaili@hust.edu.cn · +86 (027)85726808
    • Qiubai Li, MD/PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06900764
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Responsible party
Qiubai Li (Director of the Department of Rheumatology and Immunology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Mar 28, 2025
Start date
Oct 10, 2025 (estimated)
Primary completion
Nov 15, 2027 (estimated)
Completion
Dec 20, 2027 (estimated)
Last update
Jul 17, 2025

Study contacts

Qiubai Li, MD/PhD
Contact
qiubaili@hust.edu.cn
+86 (027)85726808

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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