NCT06691152 Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus
| NCT ID | NCT06691152 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2024-10-30 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an investigator-initiated trial to evaluate the safety and efficacy of CD19 Universal CAR-T cells in the treatment of refractory systemic lupus erythematosus.
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. Active tuberculosis at the time of screening; 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.
Contact & Investigator
Jianhua Mao
PRINCIPAL INVESTIGATOR
The Children's Hospital of Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06691152 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06691152 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06691152 currently recruiting?
Yes, NCT06691152 is actively recruiting participants. Contact the research team at maojh88@zju.edu.cn for enrollment information.
Where is the NCT06691152 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06691152 clinical trial?
NCT06691152 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The principal investigator is Jianhua Mao at The Children's Hospital of Zhejiang University School of Medicine. The trial plans to enroll 18 participants.
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