Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients
This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.
• 18-70 years old;
• Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria;
• LLDAS response criteria are not achieved after administration with at least two immunosuppressants (including, but not limited to, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, ciclosporin and iguratimod) and/or at least one approved biological agent for more than 6 months.
• 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;