C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease

Exclusion Criteria

• •1. Any other concomitant diseases requiring long term systemic steroids (oral or intravenously) treatment that may confound the interpretation of study results or have interference with background steroid tapering for the subjects.
• •2. Any of the following:
• •* Positive for Hepatitis B surface antigen (HBsAg)/core antibody (HBcAb)/e antibody (HBeAb)/e antigen (HBeAg).
• •* Positive for Hepatitis C Virus (HCV) antibodies.
• •* Positive for Human Immunodeficiency Virus (HIV) antibodies.
• •* Positive for syphilis antigen or antibody.
• •3. Have an uncontrolled active infection.
• •4. History of major organ transplantation (such as heart, lung, liver, kidney) or history of bone marrow/hematopoietic stem cell transplantation.
• •5. History of any of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening.
• •6. History of ≥ Grade 2 bleeding within the past 30 days.
• •7. Received a live vaccine within 4 weeks prior to signing the ICF.
• •8. Received any of the following treatments:
• •* Prednisone treatment of ≥ 100 mg/d or equivalent corticosteroid therapy for ≥14 days within the previous 8 weeks.
• •* Receive plasma exchange, plasma separation, hemodialysis, or intravenous injection of immunoglobulin (IVIG) within 14 days prior to leukapheresis.
• •* Use of any other investigational clinical study drug within 28 days prior to leukapheresis. However, if the subject is not responsive to the treatment or have progressed and at least 3 half-lives have passed before the leukapheresis, he/she could be enrolled.
• •* Previously received any CAR-T cell products or other genetically modified T cell therapies.
• •* Rituximab/ocrelizumab/obinutuzumab within 6 months prior to screening
• •9. Pregnant or breastfeeding women.
• •10. History of seizure disorder, cerebrovascular ischemia/hemorrhage, dementia or cerebellar disease or other severe neuropsychiatric syndromes.
• •11. History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated DVT is allowed)
• •12. Diagnosed with malignant tumors within 5 years prior to signing the ICF, with the following exceptions: non-melanoma skin cancer that has been treated with radical therapy, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely excised breast carcinoma in situ.
• •13. Poor compliance, unwilling or unable to adhere to the study protocol based on the investigator's assessment.
• •14. Allergies to fludarabine, cyclophosphamide and/or known allergies to excipients of C-CAR168 cell product.