Acute Myeloid Leukemia
Conditions
Brief summary
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.
Detailed description
The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.
Interventions
BIOLOGICALCART-19
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19 cells/kg).
Sponsors
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia * Age 6-65 years. * Left ventricular ejection fractions≥ 0.5 by echocardiography. * Creatinine \< 1.6 mg/dL. * Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal. * Bilirubin \<2.0 mg/dL. * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion criteria
* Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Class III/IV cardiovascular disability according to the New York Heart Association Classification. * HIV infection. * Patients with history of seizure * Active central nervous system leukemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months | Adverse events are evaluated with CTCAE V4.03 |
Countries
China
Contacts
Primary ContactXiaowen Tang, Ph.D.
Backup ContactLei Yu, Ph.D.
Outcome results
None listed