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 persistence and cell phenotype of CAR-T cells in vivo and CAR-T treatment-related inflammatory factors were evaluated after treatment. To explore new therapeutic methods, in order to reduce the side effects of traditional therapeutic drugs, increase curative effect, and finally make patients obtain long-term survival and improve survival quality.
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;
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;