Dose Optimization Trial of Autologous T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor (CART-19) in Patients With Relapsed or Refractory CD19+ Chronic Lymphocytic Leukemia (CLL)
This study is being conducted to determine the optimal dose of autologous CART-19 T cells
engineered to express anti-CD19 chimeric antigen receptors in patients with relapsed or
refractory CD19 positive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
(SLL). The two dose levels being assessed are 1-5x10e8 versus 1-5x10e7. The trial will be
conducted in two stages. In stage I subjects will be randomized into one of the two dose
cohort with a1:1 ratio for a total of 12 subjects per dose cohort. Stage II will be to
enroll an additional 8 subjects to the selected dose cohort once safety, tolerability and
clinical responses have been evaluated to determine the optimal dose cohort.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Adverse Events
12 months
Yes
Noelle Frey, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 03712
NCT01747486
December 2012
December 2015
Name | Location |
---|---|
Abramsonc Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |