A Clinical Study of Anti-CD19 CAR-NK Cells in the Treatment of Refractory/Relapsed Systemic Lupus Erythematosus

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

This study is a single-center, open-label, single-arm trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up;

• Age range from 18 to 65 years old, regardless of gender;

• Fulfilling the 2019 ACR/EULAR classification criteria of SLE;

• Presence of anti-dsDNA or decreased C3/C4 levels;

• SLEDAI-2K≥8;

• Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use more than two drugs, including glucocorticoid (more than 1mg/kg/d), and any two or more of the following immunomodulatory drugs for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, ciclosporin, iguratimod, biological agents, including rituximab, belizumab, or telitacicept;

• Hemoglobin ≥ 80g/L; white blood cell count ≥ 3 × 10\^9/L;neutrophil count ≥ 1.5 × 10\^9/L; platelets ≥ 30 × 10\^9/L;

• The functions of important organs are basically normal: ALT ≤ 2 × ULN; AST ≤ 2 × ULN; eGFR ≥ 30ml/min/1.73m2; total bilirubin ≤2.0 mg/dL; cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; non-oxygenated blood oxygen saturation \>94%; prothrombin time (PT) ≤ 1.5 × ULN;international standardized ratio (INR) ≤ 1.5 × ULN;

• Females of childbearing potential must use effective contraception during the study.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Huaxiang Wu, PhD
wuhx8855@zju.edu.cn
86-13757118395
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 10
Treatments
Experimental: anti-CD19 CAR-NK cells
To evaluate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR-NK cells infusion on Day 0, 3, and 6.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov