refractory/relapsed CD19 positive acute lymphoblastic leukemia
Conditions
Sponsors
Nagoya University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) CD19 positive ALL 2) chemo-refractory/relapsed after allogeneic stem cell transplantation 3) 1-60 years old* 4) Written informed consent from patient or legal representative 5) Fulfill all of the following criteria: i) Performance status (PS) score: 0-3 ii) AST=<5 x upper normal limit (UNL) iii) ALT=<5 x UNL iv) total bilirubin =<3 x UNL v) serum creatinine =<3 x UNL vi) SpO2>=90% (room air) *Cohort 1: 16-60 years old, Cohort 2: 1-15 years old
Exclusion criteria
Exclusion criteria: 1) predonisolone use >=0.5 mg/kg 2) BM blast >=20% 3) CNS-3 4) isolated extramedullary leukemia 5) severe or uncontrollable infection 6) severe or uncontrollable GVHD 7) severe or uncontrollable heart failure 8) previous use of CAR-T therapy 9) previous use of CD3/CD19 bispesific antibody 10) Psychoses 11) History of allergic reaction to albumin 12) History of allergic reaction to mouse derived protein
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLT until 4 weeks after CAR-T infusion | — |
Countries
Japan
Contacts
Public ContactNobuhiro Nishio
Nagoya University Hospital Center for Advanced Medicine and Clinical Research
Outcome results
None listed