Table 4.

Differences between Pilot Clinical Trial and Current Phase I Clinical Trial

Pilot Clinical Trial [10-11]	Phase I Clinical Trial (NCT01144247)
alloCTL generated in artificial capillary systems	alloCTL are generated in tissue culture bags
Source of donor responder cells derived from apheresis waste leucopaks from platelet collection	Source of donor responder cells are derived by leukapheresis
alloCTL infusates contained 60,000 IU recombinant IL-2	alloCTL infusates contain 30,000 IU recombinant IL-2
1-3 alloCTL infusates/cycle, infusates given over 7-10 days, all cells generated used for therapy, doses varied	2 alloCTL infusates/cycle, infusates given 7 days apart, doses uniform with 2-fold dose escalation
1st alloCTL injection at surgery by blunt brain cannula; subsequent infusions given through subgaleally-placed reservoir/ catheter	1st alloCTL injection at surgery or up to a few weeks later through subgaleally-placed reservoir/ catheter
Patient immune responses were not characterized	Patient immune responses are characterized; phenotypic subset response to relevant antigen monitored in vitro and correlated with response
Patients and donors were serologically HLA typed and disparate at2HLAA,Bloci	Patients and donors are molecularly HLA typed and disparities at class I and II loci typified, i.e., HLA-ABC, DR,DQ