Finding studies
Finding studies
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Lead
University of Pennsylvania
Primary objectives: 1\. To evaluate the safety and feasibility of a single target dose of 5 times 10e9 total cells, acceptable range of 1.5 times 10e7 to 5 times 10e9 total cells comprised of autologous CART-19 cells that express the TCR zeta and 4-1 BB costimulatory domain. Secondary objectives: 1. Proof of mechanism: determine if 2nd generation CAR expressing 4-1BB costimulation domains have improved persistence in patients. 2. Proof of concept: determine the effects of CART-19 on CD19 expression in vivo. 3. Proof of bioactivity: Evaluate changes in systemic soluble immune factors in patients 4. Proof of bioactivity: Evaluate impact of CART19 treatment on tumor burden 5. Explore whether CART-19 cells retain anti-tumor activity in vivo. 6. Determine if host immunity develops against CART-19. 7. Characterize the relative subsets of CART-19 T cells (Tcm, Tem, and Treg). 8. Describe survival and response rates
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted