RecruitingPhase 1NCT07233642

Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE

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

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

18 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 5 Years

Inclusion Criteria11

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.

Exclusion Criteria14

Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
Severe acute nephritis: patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or mycophenolate mofetil treatment;
Have a history of congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patients with unstable vital signs who need hypertensive drugs;
Uncontrollable infection, or active infection that requires systemic treatment within 3 months prior to screening;
Received organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to screening;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;
Suffered from macrophage activation syndrome(MAS) within 1 month prior to screening (except for those whose safety risks have been ruled out by the researcher after treatment);
Received CAR-T treatment (except for those whose safety risks have been ruled out by the researchers after treatment);
Suffered from active pulmonary tuberculosis at screening;
Received live vaccine within 4 weeks prior to screening;
Positive in Blood pregnancy test;
Previous or concurrent malignancy;
Patients who participated in other clinical study within 3 months prior to screening;
Any other conditions that the investigators deem it unsuitable for the study.

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Interventions

BIOLOGICALCD19 CAR-T cells

Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.