NCT03896854RecruitingPhase 1
Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd1 site in 1 country15 target enrollmentStarted: October 18, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Adverse events
Time Frame: 12 months
Adverse events are evaluated with CTCAE V4.03
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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