As for safety, I know they looked at product characteristics and showed Grade >3 ICANS correlated strongly with the effective stem central memory phenotype CD4+ T-cell dose, differentiated CD4+CCR7- T-cell dose and CD4:CD8 ratio. In addition, other factors, such as tumour burden and Cmax of IL-6, IL-2 and IP10 did. Interestingly, IL-6 plays a role in CRS (S)AEs https://ashpublications.org/blood/article/130/21/2295/36661/Kinetics-and-biomarkers-of-severe-cytokine-release
The new manufacturing protocol was intended to maximise the stem central memory phenotype T-cell fraction (CCR7+), while limiting the CD4+ CCR7- differentiated fraction, that could improve the safety and efficacy of the product. Looking at the poster, the median, desired memory T-cell proportion from Process 1.0 to 1.1b increased from 52.75% to 75.00%. Median healthy cells proportion from Process 1.0 to 1.1b increased from 15.67% to 43.20%, and CD4:8 range decreased from 25.16% to 2.47%.
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