Pharmacokinetic parameters determined over the complete treatment course
| Patient no. (dose, mg/m2) . | IT . | T1/2(h) . | AUC (mg × h/mL) . | Cl (L/h) . | Vd (L) . | Cmax (ng/mL) . |
|---|---|---|---|---|---|---|
| 1 (2, 2, 4) | SPV-T3a-dgA | 3.4 ± 0.6 | 5.6 ± 0.6 | 0.36 ± 0.04 | 1.8 ± 0.2 | 1830 |
| WT1-dgA | 5.5 ± 1.2 | 5.3 ± 0.8 | 0.37 ± 0.06 | 3.0 ± 0.3 | 1380 | |
| IT-combination | 4.0 ± 0.7 | 10.5 ± 1.3 | 0.19 ± 0.02 | 1.1 ± 0.1 | 3210 | |
| 2 (2, 2, 4, 4) | SPV-T3a-dgA | 6.5 ± 1.0 | 3.4 ± 0.3 | 0.59 ± 0.06 | 5.6 ± 0.5 | 720 |
| WT1-dgA | 6.7 ± 1.4 | 3.9 ± 0.5 | 0.52 ± 0.07 | 5.0 ± 0.6 | 930 | |
| IT-combination | 6.6 ± 1.2 | 7.3 ± 0.8 | 0.28 ± 0.03 | 2.6 ± 0.3 | 1650 | |
| 3 (4, 4, 4, 4) | SPV-T3a-dgA | 6.9 ± 0.8 | 9.5 ± 0.7 | 0.64 ± 0.05 | 6.4 ± 0.4 | 675 |
| WT1-dgA | 9.1 ± 1.4 | 3.4 ± 0.3 | 0.58 ± 0.06 | 7.6 ± 0.6 | 545 | |
| IT-combination | 6.9 ± 0.8 | 12.4 ± 0.9 | 0.32 ± 0.02 | 3.2 ± 0.2 | 1220 | |
| 4 (4, 4, 4) | SPV-T3a-dgA | 9.2 ± 1.5 | 12.2 ± 1.1 | 0.32 ± 0.03 | 4.4 ± 0.4 | 910 |
| WT1-dgA | 8.8 ± 2.7 | 7.5 ± 1.3 | 0.54 ± 0.09 | 6.8 ± 1.2 | 668 | |
| IT-combination | 9.1 ± 1.9 | 19.7 ± 2.3 | 0.20 ± 0.02 | 2.7 ± 0.3 | 1560 |
| Patient no. (dose, mg/m2) . | IT . | T1/2(h) . | AUC (mg × h/mL) . | Cl (L/h) . | Vd (L) . | Cmax (ng/mL) . |
|---|---|---|---|---|---|---|
| 1 (2, 2, 4) | SPV-T3a-dgA | 3.4 ± 0.6 | 5.6 ± 0.6 | 0.36 ± 0.04 | 1.8 ± 0.2 | 1830 |
| WT1-dgA | 5.5 ± 1.2 | 5.3 ± 0.8 | 0.37 ± 0.06 | 3.0 ± 0.3 | 1380 | |
| IT-combination | 4.0 ± 0.7 | 10.5 ± 1.3 | 0.19 ± 0.02 | 1.1 ± 0.1 | 3210 | |
| 2 (2, 2, 4, 4) | SPV-T3a-dgA | 6.5 ± 1.0 | 3.4 ± 0.3 | 0.59 ± 0.06 | 5.6 ± 0.5 | 720 |
| WT1-dgA | 6.7 ± 1.4 | 3.9 ± 0.5 | 0.52 ± 0.07 | 5.0 ± 0.6 | 930 | |
| IT-combination | 6.6 ± 1.2 | 7.3 ± 0.8 | 0.28 ± 0.03 | 2.6 ± 0.3 | 1650 | |
| 3 (4, 4, 4, 4) | SPV-T3a-dgA | 6.9 ± 0.8 | 9.5 ± 0.7 | 0.64 ± 0.05 | 6.4 ± 0.4 | 675 |
| WT1-dgA | 9.1 ± 1.4 | 3.4 ± 0.3 | 0.58 ± 0.06 | 7.6 ± 0.6 | 545 | |
| IT-combination | 6.9 ± 0.8 | 12.4 ± 0.9 | 0.32 ± 0.02 | 3.2 ± 0.2 | 1220 | |
| 4 (4, 4, 4) | SPV-T3a-dgA | 9.2 ± 1.5 | 12.2 ± 1.1 | 0.32 ± 0.03 | 4.4 ± 0.4 | 910 |
| WT1-dgA | 8.8 ± 2.7 | 7.5 ± 1.3 | 0.54 ± 0.09 | 6.8 ± 1.2 | 668 | |
| IT-combination | 9.1 ± 1.9 | 19.7 ± 2.3 | 0.20 ± 0.02 | 2.7 ± 0.3 | 1560 |
T1/2 indicates plasma half-life; AUC, area under the concentration versus time curve; Cl, clearance; Vd, volume of distribution; and Cmax, maximum plasma concentration.