Efficacy and Safety Study of CD19 Universal CAR T Cells in 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 to evaluate the safety and efficacy of CD19 Universal 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;

• Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria;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 of the following treatments(cyclophosphamide, MMF, 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: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No serious lung lesions, SpO2≥92%;

• Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;

• Negative pregnancy test for female Subjects of childbearing age, 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, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianhua Mao, Prof
maojh88@zju.edu.cn
0571-86670076
Backup
Xue He
6511009@zju.edu.cn
15088688407
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 18
Treatments
Experimental: CAR T cell treatment group
This trial was designed as an open, single-arm, multicenter, dose-increasing trial, three dose groups (1×10\^7/kg, 3×10\^7/kg, 6×10\^7/kg) are set up, starting from the low dose group to explore the safe and effective dose.
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov