TABLE 2.
Manufacturing and phenotype of infused DCreg products
| Recipient ID | # Donor leukaphereses | # Donor monocytes elutriated (×109) | Viability (%) | # DCregs generated (×106) | # DCregs infused (×106) | Dose infused (DCreg 106/kg)a | IL−10:IL−12 ratiob | PD-L1/CD86 ratioc |
|---|---|---|---|---|---|---|---|---|
| Pat 1001 | 1 | 1.9 | 88 | 603 | 543 | 5.3 | 7 | 3.7 |
| Pat 1002 | 2 | 1.6 | 83 | 346 | 311 | 2.9 | 10 | 3.6 |
| Pat 1003 | 1 | 2.6 | 96 | 655 | 590 | 7.0 | 105 | 5.3 |
| Pat 1004 | 1 | 2.0 | 98 | 625 | 563 | 5.3 | 26 | 9.3 |
| Pat 1005 | 1 | 1.7 | 95 | 374 | 354 | 4.1 | 22 | 3.0 |
| Pat 1006 | 1 | 2.0 | 98 | 498 | 473 | 8.3 | 48 | 3.8 |
| Pat 1007 | 1 | 3.0 | 98 | 499 | 456 | 8.7 | 40 | 1.2 |
| Pat 1008 | 1 | 1.6 | 100 | 320 | 298 | 4.0 | 45 | 2.3 |
| Pat 1009 | 2 | 2.5 | 97 | 565 | 548 | 4.2 | 52 | 3.5 |
| Pat 1010 | 1 | 1.5 | 97 | 568 | 547 | 8.3 | 79 | 3.6 |
| Pat 1011 | 1 | 2.4 | 89 | 245 | 221 | 3.2 | 15 | 1.8 |
| Pat 1012 | 1 | 1.3 | 91 | 379 | 348 | 4.6 | 34 | 7.5 |
| Pat 1013 | 1 | 0.7 | 94 | 141 | 137 | 1.6d | 27 | 5.8 |
| Pat 1015 | 1 | 1.5 | 97 | 245 | 240 | 2.6 | 89 | 3.5 |
| Pat 1016 | 1 | 1.6 | 92 | 377 | 368 | 4.1 | 17 | 4.5 |
| Mean (±SD) | – | 1.9 (±0.6) | 94 (±5) | 429 (±157) | 400 (±142) | 4.9 (±2.2) | 41 (±30) | 4.2 (±2.1) |
a
Target cell dose: 2.5–10 × 106/kg.
b
IL-10:IL-12 ratio post-release; stimulation with J558-CD40L cell line.
c
PD-L1/CD86 ratio >2.5 indicating DCreg phenotype, post-release.
d
Sub-target dose infused.