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)
Who is this study for? Child to adult patients with CD19-Positive Acute Myeloid Leukemia
What treatments are being studied? CD19-Positive CAR-T Cells
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 65
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Xiaowen Tang, Ph.D.
tangxiaowen@suda.edu.cn
(0086)51267781856
Backup
Lei Yu, Ph.D.
ylyh188@163.com
(0086)13818629089
Time Frame
Start Date: 2017-10-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 15
Treatments
Experimental: CD19 positive relapsed or refractory acute myeloid leukemia
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
Related Therapeutic Areas
Sponsors
Leads: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd