Table 3.
Summary of cellular kinetic parameters stratified by response.
| Parameters | CR/PR | PD/SD/Unknown | All Patients | |
|---|---|---|---|---|
| N = 23 | N = 9 | N = 32 | ||
| AUC0–28d (copies/μg*days) | ||||
| N | 23 | 6 | 29 | |
| Geometric mean | 1,635,220.0 | 564,240.7 | 1,212,189.4 | |
| CV% | 110.3 | 158.4 | 124.8 | |
| Fold difference (responders vs non-responders) | 289% | |||
| AUC0–84 d (copies/μg*days) | ||||
| N | 18 | 4 | 22 | |
| Geometric mean | 1,971,703.9 | 752,917.4 | 1,655,101.1 | |
| CV% | 113.8 | 61.9 | 122.6 | |
| Fold difference (responders vs non-responders) | 262% | |||
| Cmax (copies/μg) | ||||
| N | 23 | 9 | 32 | |
| Geometric mean | 331,312.1 | 197,118.8 | 286,294.4 | |
| CV% | 107.1 | 272.8 | 346.8 | |
| Fold difference (responders vs non-responders) | 168% | |||
| Tmax (days) | ||||
| n | 23 | 9 | 32 | |
| Median | 12 | 12 | 12 | |
| Min, max | 2, 25 | 1, 28 | 1, 28 | |
| Tlast (days) | ||||
| n | 23 | 9 | 32 | |
| Median | 133 | 22 | 92.5 | |
| Min, max | 15, 763 | 13, 174 | 13, 763 | |
CR, complete response; PR, partial response; PD, progressive disease; SD, stable disease; AUC, area under the curve; CV, coefficient of variation; Cmax, maximal expansion of transgenic T cell levels in peripheral blood after the infusion; Tmax, time to maximal expansion; Tlast, T cells are present in peripheral blood.