Treatment timepoint | Day | CAR T-cell levels | CRP (ng/mm3) | Ferritin (pg/mm3) | IFN-γ (pg/mm3) | IL-15 (pg/mm3) | IL-2 (pg/mm3) | MCP-1 (pg/mm3) | CXCL10 (pg/mm3) |
Pre-conditioning chemotherapy | −5 | -- | 5.04 | 432.8 | 0.0075 | 0.0014 | 0.0009 | 0.2957 | 0.3908 |
Post-conditioning chemotherapy/pre-KTE-X19 | 0 | -- | 6.84 | 606.3 | 0.0075 | 0.0291 | 0.0009 | 0.4626 | 0.4882 |
Post-KTE-X19/pre-ATG | 3 | N/A | 18.24 | 824.2 | 0.5844 ↑ | 0.0561 ↑ | 0.0167 ↑ | 1.500 ↑ | 2.000 ↑ |
Post-ATG | 7 | 431.3 cells/mm3 | 2.69 ↓ | 1397.8 | 0.0075 ↓ | 0.0036 ↓ | 0.0009 ↓ | 0.0969 ↓ | 0.937 ↓ |
8* | In CSF (cells/mm3): CD4:CD8 ratio 1 CD3+/CAR +4.3 × 10−3 CD4+/CAR +1.7 × 10−3 CD8+/CAR+ 0.6 × 10−3 CD14+ 16.4 × 10−3 CD19+ undetected NK undetected CD66b+ 18.1 × 10−3 | 0.049 | N/A | 0.0075 | 0.0014 | 0.0009 | 1.3853 | 3.2552 | |
14 | <1 cell/mm3 | 0.35 | 1300.3 | 0.0075 | 0.0633 | 0.0009 | 0.2010 | 0.0979 | |
28 | 3.0 cells/mm3 | <0.0001 | 737.6 | 0.1249 | 0.0150 | 0.0009 | 0.4758 | 0.3374 |
Up arrows (↑) indicate serum analytes with high peak levels on day 3 (post-KTE-X19 and pre-ATG) within or higher than the top quartile of other patients in ZUMA-2. Down arrows (↓) indicate serum analytes with a sharp reduction on day 7 following implementation of ATG on day 6.
*CAR-T cell levels were measured in peripheral blood and cytokines were measured in serum except for day 8 (CSF).
CAR, chimeric antigen receptor; CRP, C reactive protein; CSF, cerebrospinal fluid; CXCL10, IFN-γ-induced protein 10; IFN-γ, interferon gamma; IL, interleukin; MCP-1, monocyte chemoattractant protein 1; N/A, not available.