CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Phase 1
Recruiting
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT03896854
- Lead Sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events 12 months Adverse events are evaluated with CTCAE V4.03
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University🇨🇳Suzhou, Jiangsu, ChinaXiaowen Tang, Ph.D.Contact