Donor Treg DLI product characteristics
| Cell doses . | Median (range) . |
|---|---|
| Starting apheresis viable TNC | 2.43 × 1010 (0.99 × 1010, 5.95 × 1010) |
| MRD collected locally | 2.83 × 1010 (1.47 × 1010, 3.53 × 1010) |
| URD from collection site | 2.20 × 1010 (0.99 × 1010, 5.95 × 1010) |
| % Treg∗ of apheresis | 3.40% (1.90, 5.26) |
| Final viable TNC after selection | 1.08 × 108 (0.54 × 108, 3.07 × 108) |
| Viable TNC infused per kg | |
| Dose level A | 0.1 × 106/kg |
| Dose level B | 0.3 × 106/kg |
| Dose level C | 1.00 × 106/kg (0.58 × 106, 1 × 106) |
| Treg cells∗ infused per kg | |
| Dose level A | 9.19 × 104/kg (6.68 × 104, 9.47 × 104) |
| Dose level B | 2.69 × 105/kg (2.49 × 105, 2.87 × 105) |
| Dose level C | 7.60 × 105 (5.11 × 105, 9.31 × 105) |
| Selection efficiency | |
| CD8+ log depletion† | 4.4 (3.5, 5.1) |
| CD20+ log depletion† | 4.4 (3.1, 5.3) |
| % CD4+ CD25hi of leukocytes | 92.9% (82.7, 98.1) |
| % CD4+ CD25+ CD127lo of leukocytes | 88.4% (66.8, 98.5) |
| Treg∗ fold enrichment | 26.6 (12.7, 44) |
| Treg∗ % recovery over process | 14.9% (5.6, 30.5) |
| Cell doses . | Median (range) . |
|---|---|
| Starting apheresis viable TNC | 2.43 × 1010 (0.99 × 1010, 5.95 × 1010) |
| MRD collected locally | 2.83 × 1010 (1.47 × 1010, 3.53 × 1010) |
| URD from collection site | 2.20 × 1010 (0.99 × 1010, 5.95 × 1010) |
| % Treg∗ of apheresis | 3.40% (1.90, 5.26) |
| Final viable TNC after selection | 1.08 × 108 (0.54 × 108, 3.07 × 108) |
| Viable TNC infused per kg | |
| Dose level A | 0.1 × 106/kg |
| Dose level B | 0.3 × 106/kg |
| Dose level C | 1.00 × 106/kg (0.58 × 106, 1 × 106) |
| Treg cells∗ infused per kg | |
| Dose level A | 9.19 × 104/kg (6.68 × 104, 9.47 × 104) |
| Dose level B | 2.69 × 105/kg (2.49 × 105, 2.87 × 105) |
| Dose level C | 7.60 × 105 (5.11 × 105, 9.31 × 105) |
| Selection efficiency | |
| CD8+ log depletion† | 4.4 (3.5, 5.1) |
| CD20+ log depletion† | 4.4 (3.1, 5.3) |
| % CD4+ CD25hi of leukocytes | 92.9% (82.7, 98.1) |
| % CD4+ CD25+ CD127lo of leukocytes | 88.4% (66.8, 98.5) |
| Treg∗ fold enrichment | 26.6 (12.7, 44) |
| Treg∗ % recovery over process | 14.9% (5.6, 30.5) |