T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
• 18-90 years old;
• Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
• SELENA-SLEDAI≥8.
• Patients with CD19+ B-cell.
• Hemoglobin≥85 g/L.
• WBC≥2.5×10\^9/L.
• NEUT≥1×10\^9/L.
• BPC≥50×10\^9/L.
• AST/ALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL/min; blood bilirubin ≤2.0 mg/dl; echocardiography indicates that the ejection fraction is ≥50%.
• Adequate venous access for apheresis, and no other contraindications for leukapheresis.
• Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.
• Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.
• Agree to attend follow-up visits as required.
• Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.