Search / Trial NCT06222853

Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Jan 15, 2024

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Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Systemic Lupus Erythematosus Car T

Description

Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death. Children with SLE are particularly at risk of organ damage, especially to the kidneys, and tend to have a more severe and protracted course of the disease compared to adults. Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients often require lifelong medication. In recent years, biological...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age:≥5 years old;
  • 2. 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;
  • 3. SLEDAI 2K score≥8 points;
  • 4. 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%;
  • 5. Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;
  • 6. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;
  • 7. 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 Criteria:
  • 1. Received CAR T cell therapy previously;
  • 2. Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
  • 3. 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 MMF treatment;
  • 4. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; 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；
  • 5. Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
  • 6. Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
  • 7. History of organ transplantation or hematopoietic stem cell transplantation, or ≥Grade 2 GVHD within 2 weeks prior to screening；
  • 8. 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; Or cytomegalovirus (CMV) DNA test positive;
  • 9. Received live vaccine within 4 weeks before screening;
  • 10. Tested positive in Blood pregnancy test；
  • 11. Previous or concurrent malignancy；
  • 12. Patients who participated in other clinical study within 3 months prior to enrollment;
  • 13. Any other conditions that the investigators deem it unsuitable for the study.

About The Children's Hospital Of Zhejiang University School Of Medicine

The Children's Hospital of Zhejiang University School of Medicine is a leading pediatric medical institution dedicated to advancing child health through innovative research and clinical excellence. Affiliated with Zhejiang University, this hospital is at the forefront of pediatric healthcare, offering a comprehensive range of specialized services and cutting-edge treatments. Its commitment to clinical trials underscores its mission to improve pediatric care, facilitating the development of new therapies and interventions that address the unique health challenges faced by children. With a focus on collaboration and scientific integrity, the institution actively contributes to the global pediatric research community.

Locations

Hangzhou, Zhejiang, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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