A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia

Exclusion Criteria21

• Participants with T-cell leukaemia and Burkitt's M3 leukaemia.
• Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).
• Inadequate organ function, evidenced by the following laboratory results:
• Serum creatinine ≥ 2 mg/dL
• Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)
• Total bilirubin ≥ 2 mg/dL
• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.
• History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as > 20 mg of prednisone or equivalent daily.
• History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
• History of receiving allograft organ transplant requiring immunosuppression.
• Participants post solid organ transplant who develop high grade lymphomas or leukaemias.
• Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
• History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.
• Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids defined as > 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.
• Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
• History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and a detectable HIV viral load.
• Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
• Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
• Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
• Women who are pregnant or breastfeeding.