Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia

Prior treatment

• Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2 weeks.
• Received HSCT within 12 weeks before enrollment.
• Concurrent use of systemic steroids or immunosuppressive agents (except for replacement therapy and local administration. e.g. inhalation, application and so on).
• History of allergy about component of investigational product or animal(cattle and/or mouse)-derived additives

Other illness

• HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA \> 1.3LogIU/ml
• Presence of active hepatitis C infection
• HIV Ab or anti-HTLV-1 Ab positive
• Hypersensitivity to antibiotics.
• Presence of symptomatic cardiac arrhythmias or serious heart disease.
• Presence of another malignant tumor.
• Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of informed consent.
• Active or serious infection.

Lab values

• White blood cell counts ≧ 50,000/uL
• lymphocytes except for blasts ≦ 500/uL

Other

• Under treatment for GVHD.
• Presence of active CNS-3
• Both men and women who have generative functions, and who cannot agree with using contraceptive devices from the day of the consent to the end of study.
• Pregnant or lactating women.
• Any other patients judged by the investigators to be inappropriate for the study.

• In phase-1 study, patients must be ≥ 18 years of age. In phase-2 study, patients must be ≥ 16 years of age.
• Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined below
  • Total bilirubin level ≤1.5xULN (Upper limit of normal)
  • AST(GOT)/ALT(GPT) level ≤5.0xULN
  • Serum creatinine ≤2.0mg/dL
  • SpO2 ≧ 92%
  • LVEF ≥50%
• Patients must be able to understand and willing to sign a written informed consent document (for patients \<20 years of age their legal guardian must give informed consent).