CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)

Exclusion Criteria

• •1. Isolated extra-medullary disease relapse.
• •2. Active CNS involvement of ALL (CNS Grade 3 per National Comprehensive Cancer Network guidelines).
• •3. Active infectious bacterial or viral disease requiring IV anti-microbials for treatment.
• •4. Females who are pregnant or lactating.
• •5. Females of child-bearing potential and post pubertal male participants who are unwilling to use highly effective methods of contraception for a period of 1 year after the AUTO3 infusion.
• •6. Inability to tolerate leukapheresis.
• •7. Prior CD19 or CD22 targeted therapy with Grade 4 toxicity or ≥refractory Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug related CNS toxicity.
• •8. Pre-existing significant neurological disorder.
• •9. Stem Cell Transplant patients only: active significant acute graft versus host disease (GVHD) or moderate/severe chronic GVHD requiring systemic steroids or other immunosuppressant within 4 weeks of enrolment.
• •10. The following medications are excluded:
• •1. Steroids: Therapeutic doses of steroids must be stopped \>72 hours prior to AUTO3 infusion and leukapheresis. However, physiological replacement doses of steroids are allowed: \<12 mg/m2/day hydrocortisone or equivalent.
• •2. Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed \>6 weeks prior to AUTO3 infusion.
• •3. Graft versus host disease therapies: Any drug used for GVHD must be stopped \>4 weeks prior to AUTO3 infusion.
• •4. Chemotherapy: Should be stopped 1 week prior to leukapheresis and 2 days prior to starting pre-conditioning chemotherapy.
• •11. Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.
• •1. Severe intercurrent infection.
• •2. Requirement for supplementary oxygen.
• •3. Allogeneic transplant recipients with active significant acute GVHD overall Grade ≥II or moderate/severe chronic GVHD requiring systemic steroids.