Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
Recruiting now · Phase 1
Conditions studied: Systemic Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT07233642
- Run by
- The Children's Hospital of Zhejiang University School of Medicine
- People needed
- 18
- Starts
- 2025-11-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2025-11-18
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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