RecruitingPhase 1NCT06691152

Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus

Efficacy and Safety Study of CD19 Universal CAR T Cells in Refractory Systemic Lupus Erythematosus

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

18 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus

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

Min Age: 5 Years

Inclusion Criteria8

Age:≥5 years old;
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;
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: 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%;
Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;
Negative pregnancy test for female Subjects of childbearing age, 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 Criteria13

Received CAR T cell therapy previously;
Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
Active tuberculosis at the time of screening;
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；
Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
History of organ transplantation or hematopoietic stem cell transplantation, 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; Or cytomegalovirus (CMV) DNA test positive;
Received live vaccine within 4 weeks before screening;
Tested positive in Blood pregnancy test；
Previous or concurrent malignancy；
Patients who participated in other clinical study within 3 months prior to enrollment;
Any other conditions that the investigators deem it unsuitable for the study.