A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases
A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.
• Age: 18\
‣ 65 years old
• Diagnosis of B-cell mediated autoimmune rheumatic diseases - SLE, SSc, IIM, RA.
• Expected survival period ≥ 3 months;
• Serum creatinine \<221.0μmol/L (2.5mg/dl);
• AST/ALT below 3 times the upper limit of normal, blood bilirubin \<34.2 μmol/L (2.0 mg/dl);
• Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;
• No obvious active infection;
• Physical fitness score 0\
‣ 2 points (ECOG standard);
• There are suitable veins for blood cell apheresis or whole blood collection, and there are no contraindications for blood collection;
⁃ Women of childbearing age should have a negative serum or urine pregnancy test 48 hours before CAR T cell reinfusion, and agree to take effective contraceptive measures during the trial until the last follow-up;
⁃ Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative;