This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.
Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
SLEDAI-2000 score >6.
Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for >6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
Presence of neuropsychiatric lupus (NPSLE).
History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
History of severe drug allergies or hypersensitivity.
Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).