This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of anti-CD123 CAR-T cells in treating patients diagnosed with refractory/relapsed acute leukemia in a dose-escalation way.
This is a dose-escalation study of autologous anti-CD123 CAR-T cells. Patients receive fludarabine phosphate(300 mg/m\^2) and cyclophosphamide (30 mg/m\^2) IV on days -5 to -3, and then Patients receive autologous anti-CD123 CAR T cells IV over 20 minutes on day 0 (20% of total dose), day2 (30% of total dose) and day6 (50% of total dose, according to the side-effects occured). The total dose of CAR-T cells used in dose-escalation study is 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Patients receive fludarabine phosphate(300 mg/m\^2) and cyclophosphamide (30 mg/m\^2) IV on days -5 to -3, and then Patients receive autologous anti-CD123 CAR T cells IV over 20 minutes on day 0 (20% of total dose), day2 (30% of total dose) and day6 (50% of total dose, according to the side-effects occured). The total dose of CAR-T cells used in dose-escalation study is 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Dose-limiting toxicity (DLT)
assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: 28 days
Incidence of adverse events
assessed by NCI CTCAE version 4.0
Time frame: Day 1-60 months after injection
Disease response (CR or CRi)
Time frame: Day 1-60 months after injection
Survival
Time frame: Day 1-60 months after injection
Minimal residual disease
Time frame: Day 1-60 months after injection
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