Biomarker Median±IQR | Controls | CAR-T cell patients (baseline) | P value (CAR-T at baseline vs control) | CAR-T cell patients (24h-INF) | P value (CAR-T at 24h-INF vs control) | CAR-T cell patients (Tox-onset) | P value (CAR-T at Tox-onset vs control) | CAR-T cell patients (post-IMT) | P value (CAR-T at post-IMT vs control) |
N=49 | N=62 | N=62 | N=19 | N=19 | |||||
sVCAM-1 (ng/mL) | 77±27 | 176±283 | <0.001* | 203±362 | <0.001* | 359±455 | <0.001* | 498±1078 | <0.001* |
sTNFRI (pg/mL) | 291±106 | 2467±2076 | <0.001* | 2678±2350 | <0.001* | 4252±4733 | <0.001* | 3052±4096 | 0.001* |
TM (ng/mL) | 14±13 | 3164±1645 | <0.001* | 3222±1312 | <0.001* | 3765±2938 | <0.001* | 3032±2042 | <0.001* |
ST2 (ng/mL) | 11±8 | 42±42 | <0.001* | 59±170 | <0.001* | 210±241 | <0.001* | 187±515 | <0.001* |
Ang-2 (pg/mL) | 1188±660 | 1439±999 | 0.098 | 2058±2566 | <0.001* | 2826±3660 | <0.001* | 1959±1640 | 0.002* |
NETs (µg/mL) | 1±9 | 8±5 | 0.954 | 7±3 | 0.219 | 8±5 | 0.021* | 8±4 | 0.045* |
sC5b-9 (ng/mL) | 199±66 | 516±403 | <0.001* | 472±424 | <0.001* | 689±795 | <0.001* | 685±284 | 0.001* |
VWF:Ag (%) | 107±33 | 162±137 | <0.001* | 185±136 | <0.001* | 226±111 | <0.001* | 211±98 | 0.001* |
A13 (%) | 100±12 | 90±20 | 0.009* | 75±20 | <0.001* | 74±24 | <0.001* | 65±29 | <0.001* |
α2-AP (%) | 88±45 | 112±31 | <0.001* | 108±29 | <0.001* | 92±27 | <0.001* | 100±15 | 0.001* |
PAI-1 Ag (ng/mL) | 27±16 | 29±20 | 0.180 | 32±31 | 0.211 | 39±32 | <0.001* | 41±40 | 0.281 |
Biomarker’s values from controls (in a single time point) are used for the comparison with the CAR-T cell group in each of the time points analyzed. Statistical significance (p) for the comparisons between Tox-onset versus post-IMT: sVCAM-1: 0.063; sTNFRI: 0.642; TM: 0.836; ST2: 0.501; Ang-2: 0.234; NETs: 0.196; sC5b-9: 0.098; VWF:Ag: 0.820; A13: 0.959; α2-AP: 0.234; PAI-1 Ag: 0.134.
*P<0.05.
A13, ADAMTS-13 activity; Ang-2, angiopoietin-2; Baseline, sample collected before the CAR-T cell infusion; 24h-INF, sample collected 24–48 hours after infusion; NETs, neutrophil extracellular traps; PAI-1 Ag, inhibitor of the activator of plasminogen antigen; post-IMT, sample collected 24–48 hours after immunomodulatory treatment; sC5b-9, soluble C5b9; ST2, soluble suppression of tumorigenesis-2; sTNFRI, soluble TNF receptor 1; sVCAM-1, soluble vascular cell adhesion molecule 1; TM, thrombomodulin; Tox-onset, sample collected at the suspicion of the onset of any toxicity (cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome); VWF:Ag, von Willebrand factor antigen; α2-AP, α2-antiplasmin.