Table 1. Study design for preclinical safety evaluation of CART19.

Studies	Pharmacodynamics and toxicity study	Biodistribution
Species	NSG mice	NSG mice
Age of animals	6 weeks	6 weeks
No. of animals	120 (60 males, 60 females)	48 (24 males, 24 females)
Dosage of Raji-Luc (per animal)	0, 5×105, 5×105, 5×105, 5×105	5×105
Dosages of CART19 (per animal)	0, 0, 0.2×107, 0.6×107,1.8×107	0.6×107
Route	i.v.	i.v.
Clinical observations	Daily	–
Body mass	Once per week	–
In vivo imaging	Once per week	–
Hematology	Leukocyte, lymphocyte, erythrocyte and platelet; d14, d28 and d56	–
Cytokine profile	Humanized IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF; once per week	–
hCD3+/hCD4+, hCD3+/hCD8+ analysis	d14, d28 and d56	–
hCD45+/hCD3+, hCD45+/hCD19+ analysis	–	Once per week
Quantitative analysis of CART19 in different tissues	–	Once per week
Pathological examination	d14, d28 and d56	–