Table 2. Manufacturing information and... | American Society of Hematology

Table 2.

Manufacturing information and clinical outcomes

Patient N	CD3⁺CD45⁺ T cells in harvested product, %*	Viability postthaw (first dose), %†	CAR⁺ T cells in product, %‡	Total cells per kg per dose infused§	Doses infused, N	Response, mo		Alive
Patient N	CD3⁺CD45⁺ T cells in harvested product, %*	Viability postthaw (first dose), %†	CAR⁺ T cells in product, %‡	Total cells per kg per dose infused§	Doses infused, N	1	3	Alive
1	96.6	97.2	71	2.11 × 10⁶	6	PD	—	No
2	80.1	97.1	97.5	7.46 × 10⁵	6	SD	PD	Yes
3	80.3	NA	NA	NA	NA	NA	NA	Yes
4	80.6	92.7	99	1.52 × 10⁶	6	CR	PD	Yes
5	93.5	94.4	98.3	1.23 × 10⁶	6	PR	—	Yes

Patient N	CD3⁺CD45⁺ T cells in harvested product, %*	Viability postthaw (first dose), %†	CAR⁺ T cells in product, %‡	Total cells per kg per dose infused§	Doses infused, N	Response, mo		Alive
Patient N	CD3⁺CD45⁺ T cells in harvested product, %*	Viability postthaw (first dose), %†	CAR⁺ T cells in product, %‡	Total cells per kg per dose infused§	Doses infused, N	1	3	Alive
1	96.6	97.2	71	2.11 × 10⁶	6	PD	—	No
2	80.1	97.1	97.5	7.46 × 10⁵	6	SD	PD	Yes
3	80.3	NA	NA	NA	NA	NA	NA	Yes
4	80.6	92.7	99	1.52 × 10⁶	6	CR	PD	Yes
5	93.5	94.4	98.3	1.23 × 10⁶	6	PR	—	Yes

CR, complete response; NA, not applicable; PD, progressive disease; PR, partial response; SD, stable disease.

Release specification set at 80%.

†

Release specification set at 70%.

‡

Release specification was set at 10%.

For patients weighing <80 kg (patients 1 and 4), the protocol-specified dose was 8 × 10⁵ to 1.5 × 10⁶ CAR⁺ cells per kg per dose, and for patients ≥80 kg (patients 2 and 5), the dose was 1 × 10⁸ CAR⁺ cells per dose (±20%).

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