A Feasibility and Safety Study of Concomitant Therapy With Allo-CAR-T Cells and Allo-HSCT in Patients With Relapse or Refractory Leukemia

Exclusion Criteria

• •1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
• •2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
• •3. Richter's syndrome
• •4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
• •5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
• •6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
• •7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
• •8. Patient has an investigational medicinal product within the last 30 days prior to screening
• •9. Previous treatment with investigational gene or cell therapy medicine products
• •10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
• •11. Pregnant or nursing women