Pilot Study of Redirected Autologous T-cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patient With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Adverse Events
Yes
Noelle Frey, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 04409
NCT01029366
July 2009
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |