CART22 Alone or in Combination With huCART19 for ALL

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• 6. Planned concurrent treatment with systemic steroids or immunosuppressant medications. Patients may be on a stable low dose of steroids (<10mg equivalent of prednisone) for chronic respiratory conditions or adrenal insufficiency. For additional details regarding use of steroid and immunosuppressant medications.
• 10. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.

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• 1. Active hepatitis B or active hepatitis C.
• 2. HIV Infection.
• 3. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• 4. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of eligibility confirmation by physician-investigator.
• 5. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
• 7. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.

Egyéb

• 8. Pregnant or nursing (lactating) women.

• 1. Patients with relapsed or refractory B cell ALL:
• Patients with 2nd or greater relapse or refractory to 1st salvage as defined by: i. Recurrent disease in the bone marrow identified morphologically, by immunohistochemistry or by Flow cytometry.
• Patients with extramedullary relapse only (no bone marrow involvement) will be eligible if disease response can be assessed radiographically b. Patients with refractory disease as defined by: i. Failure to achieve remission (<5% bone marrow blasts) after 2 cycles of induction chemotherapy ii. Patients that achieve remission but remain MRD+ after ≥2 cycles of induction chemotherapy.
• Patients with Ph+ ALL are eligible provided they are intolerant to or have failed tyrosine kinase inhibitor therapy.
• Patients with prior or current history of CNS3 disease* will be eligible only if CNS disease is responsive to therapy.
• *CNS disease definitions:
• CNS1 - no blasts seen on cytocentrifuge (CNS negative);
• CNS2 - total nucleated cell count <5x106/L, but blasts seen on cytocentrifuge;
• CNS3 - total nucleated cell count 5x106/L with blasts on cytocentrifuge and/or signs of CNS leukemia (i.e. cranial nerve palsy).
  • 2. For Cohort 1: Documentation of CD22 expression on malignant cells at relapse. For Cohort 2: Documentation of CD22 and/or CD19
  • 3. Adequate vital organ function defined as:
  • Creatinine ≤ 1.6 mg/dl
  • ALT/AST ≤ 3x upper limit of normal range
  • Total or Direct bilirubin ≤ 2.0 mg/dl. If Total bilirubin is ≤2.0, Direct bilirubin does not need to be assessed.
  • Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
  • 4. Male or female age ≥ 18 years.
  • 5. ECOG Performance Status that is either 0 or 1.
  • 6. No contraindications for leukapheresis.
  • 7. Subjects of reproductive potential must agree to use acceptable birth control methods.