Study of Ultra-Fast Autologous CD19-targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:

• Age: ≥ 5 years old, and no gender limitation;

• Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), hydroxychloroquine and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab) or intolerant to standard treatments;

• SLEDAI-2K score≥8 points;

• The functions of important organs are basically normal:

‣ Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram;

⁃ Renal function: eGFR≥30mL/min/1.73m2;

⁃ Liver function: AST and ALT≤3.0 ULN, total Bilirubin (TBIL) in serum ≤2.0×ULN;

⁃ Lung function: no serious lung lesions, SpO2≥92%;

• Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;

• Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures the first year after CAR-T infusion;

• Participants or their guardians agrees to participate in the clinical trial and sign the informed consent form which indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.

Locations
Other Locations
China
Children's Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianhua Mao, MD
maojh88@zju.edu.cn
13516819071
Backup
Xue He
hexue1119@163.com
15088688407
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2028-09
Participants
Target number of participants: 18
Treatments
Experimental: CAR-T treatment group
This trial was designed as an open, single-arm, single-center, dose-increasing trial.
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov