Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BCMA/CD70 CAR-T therapy for patients with systemic lupus erythematosus (SLE) who have not responded to standard treatments. The goal is to see if this therapy is safe and effective for people aged 5 and older who have been diagnosed with SLE and are experiencing moderate to severe symptoms despite trying multiple medications, including high doses of steroids.

To participate in this trial, individuals must have a certain level of disease activity and meet specific health criteria related to their heart, kidneys, liver, and lungs. Participants can expect to undergo a procedure to collect their own immune cells, which will then be modified and given back to them as treatment. If you or a loved one is considering joining this study, it's important to know that there are certain health conditions that could exclude you from participation, so discussing eligibility with a healthcare provider is essential.

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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 as follows: 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. No prior CAR-T therapy; or recurrence or poor response after previous treatment with autologous or allogeneic CAR-T targeting CD19 (as assessed by the investigator).
• • 6. Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;
• • 7. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;
• • 8. 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. Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
• • 2. 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;
• • 3. 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；
• • 4. Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
• • 5. Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
• • 6. History of organ transplantation or hematopoietic stem cell transplantation, or ≥Grade 2 GVHD within 2 weeks prior to screening；
• • 7. 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;
• • 8. Received live vaccine within 4 weeks before screening;
• • 9. Tested positive in Blood pregnancy test；
• • 10. Previous or concurrent malignancy；
• • 11. Patients who participated in other clinical study within 1 months prior to enrollment; Any other conditions that the investigators deem it unsuitable for the study.