Status:
RECRUITING
Chimeric Antigen Receptors T Cells for Refractory/Recurrent Lupus Nephritis in Children
Lead Sponsor:
Guangzhou Women and Children's Medical Center
Conditions:
Lupus Nephritis
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
The goal of this prospective, open, single-arm clinical trial was to evaluate the safety and potential efficacy of CAR T cell therapy in children with refractory/recurrent lupus nephritis. The persist...
Eligibility Criteria
Inclusion
- Age 6-18 years old (including critical value);
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria;
- According to the 2018 ISN/RPS LN standards diagnosed with active Class III or IV LN, with or without a membranous component and the biopsy must be performed within 6 months prior to screening;
- SLEDAI-2000 score ≥8 points;
- Meeting the diagnosis of refractory lupus nephritis,
- defined as treatment with two or more immunosuppressants (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolic acid analogues, leflunomide, and cyclosporine) for more than 6 months without inducing remission or relapse after remission,
- accompanied by proteinuria without remission;
- Positive expression of CD19 in peripheral blood B cells determined by flow cytometry;
- Participants had good venous access, no contraindications for cell collection;
- Participants and their guardians sign the informed consent, understand the study procedures and participate in the clinical study voluntarily;
- The functions of important organs are basically normal:
- Hematopoietic function (blood routine should meet):
- Lymphocyte count ≥1×109/L,
- White blood cell count ≥3×109/L,
- Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to examination),
- Hemoglobin ≥60g/L;
- Liver function:
- ALT≤3×ULN (except elevated ALT caused by inflammatory myopathy),
- AST≤3×ULN (except for elevated AST caused by inflammatory myopathy),
- TBIL≤1.5×ULN (except Gilbert syndrome, total bilirubin ≤3.0×ULN);
- Renal function: eGFR ≥30 ml/(min.1.73m2) (Schwartz formula, except abnormal renal function by SLE);
- Coagulation function:
- International standardized ratio (INR) ≤1.5×ULN,
- prothrombin time (PT) ≤1.5×ULN;
- Heart function: hemodynamic stability;
- Anti-nuclear antibody (ANA) ≥1:80;
- Eastern Cancer Cooperation Group (ECOG) physical status score 0 to 2.
Exclusion
- Received kidney transplant previously;
- Serious drug allergy history or allergy;
- Presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
- Complicated with severe organ dysfunction of heart, liver, lung or coagulation dysfunction;
- Complicated with congenital immunoglobulin deficiency;
- Participants with infectious diseases:
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc Ab) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range;
- Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range;
- Human immunodeficiency virus (HIV) antibody positive;
- Syphilis positive;
- Diagnosed with malignant tumors in the last five years.
- Suffer from severe central nervous system disease, mental illness and severe cognitive dysfunction;
- Participated in other clinical trials within 3 months before enrollment;
- Received CAR-T therapy previously;
- Other situations that the researcher considers unsuitable for inclusion.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06904729
Start Date
May 1 2025
End Date
April 30 2029
Last Update
April 1 2025
Active Locations (1)
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1
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong, China, 510000