Table 2.

Clinical Experience With CART Manufacturing.

CART Therapy	Number Enrolled	Manufacturing Failure % (#)	Manufactured & Not Received % (#)	Total Not Received % (#)
Tisagenlecleucel	165	7% (12)	23% (38)	30% (50)
Tisagenlecleucel (B-ALL)	92	8% (7)	11% (10)	18% (17)
Axi-cel	111	1% (1)	8% (9)	9% (10)
Liso-cel	344	<1% (2)*	14% (48)	15% (50)
KTE-X19	74	4% (3)	4% (3)	8% (3)
Ide-Cel	140	<1% (1)	8% (11)	9% (12)

Rates for failure to receive therapy due to progression of disease or other complications from time of pheresis to CART infusion are shown. Total failure to receive therapy rates range from 8% to 30%. (*8% (25/344) received a non-conforming CART product not meeting criteria for liso-cel).

Manufacturing failure rates in clinical trials for FDA approved therapies range from <1% to ~8%*.