Table 2.
Characteristics of αβ T-cell depleted cell products (target fractions).
| Patient ID | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient weight (kg) | 73 | 71 | 65 | 70 | 16 | 65 | 67 | 77 | 82 | 58 | 58 | 81 |
| ORIGINAL PRODUCT | ||||||||||||
| αβ T-cells (×106/kg) | 133.0 | 5.5 | 365.0 | 245.0 | 1370.6 | 372.9 | 227.0 | 209.7 | 200.7 | 272.5 | 394.7 | 110.4 |
| γδ T-cells (×106/kg) | 9.3 | 0.2 | 4.7 | 11.1 | 89.1 | 12.8 | 9.8 | 4.8 | 6.9 | 38.3 | 12.9 | 13.5 |
| TARGET FRACTION | ||||||||||||
| Volume (mL) | 427 | 323 | 312 | 355 | 322 | 846 | 660 | 281 | 372 | 360 | 316 | 205 |
| TNC dose (x108/kg) | 24.3 | 2.6 | 31.1 | 15.1 | 27.0 | 7.3 | 3.9 | 3.9 | 4.0 | 4.4 | 5.0 | 3.7 |
| Lymph (%) | 30.0 | 3.1 | 4.9 | 28.3 | 10.3 | 17.9 | 11 | 10.7 | 25 | 24.7 | 33.8 | 15.0 |
| Lymph (×106/kg) | 99.7 | 1.1 | 23.5 | 64.3 | 273.6 | 136.9 | 43.0 | 41.7 | 99.4 | 110.2 | 169.0 | 55.6 |
| CD3+ (% of lymph) | 20.0 | 16.8 | 9.3 | 15.3 | 10.5 | 6.3 | 8.5 | 7.5 | 4.9 | 32.6 | 5.9 | 22.2 |
| CD3+ (×106/kg) | 20.0 | 6.1 | 2.2 | 9.8 | 28.7 | 7.8 | 3.7 | 3.1 | 4.9 | 35.9 | 10.0 | 12.3 |
| αβ T-cells (% of CD3+) | 0.4 | 2.8 | 1.4 | 1.0 | 0.3 | 0.4 | 0.8 | 0.5 | 0.1 | 0.02 | 0.1 | 0.5 |
| αβ T-cells (×104/kg) | 6.7 | 0.5 | 3.0 | 11.5 | 5.0 | 3.1 | 2.9 | 3.6 | 0.3 | 0.8 | 0.8 | 0.09 |
| γδ T-cells (% of CD3+) | 98.2 | 88.1 | 97.3 | 92.2 | 99.1 | 98.6 | 98.0 | 99.1 | 99.5 | 99.5 | 99.5 | 91.6 |
| γδ T-cells (×106/kg) | 19.9 | 0.2 | 2.1 | 11.1 | 28.5 | 7.7 | 3.6 | 3.1 | 4.8 | 35.6 | 9.9 | 11.3 |
| CD19+ (% of lymph) | 48.4 | 49.3 | 24.5 | 56.3 | 58.5 | 62.3 | 54.2 | 44.9 | 58.1 | 38.7 | 52.5 | 73.9 |
| CD19+ (×106/kg) | 48.3 | 0.6 | 5.8 | 36.2 | 160.1 | 84.6 | 23.3 | 18.7 | 57.7 | 42.6 | 88.7 | 41.1 |
| CD16+/56+ (% of lymph) | 29.1 | 27.6 | 62.6 | 27.3 | 25.6 | 24.7 | 28.0 | 46.4 | 37.0 | 31.0 | 40.0 | 14.0 |
| CD16+/56+ (×106/kg) | 29.0 | 0.3 | 14.7 | 17.6 | 70.0 | 33.6 | 12.0 | 19.3 | 36.8 | 34.1 | 67.6 | 7.8 |
| CD34+ (%) | 1.8 | 1.3 | 1.2 | 1.7 | 0.7 | 0.5 | 1.7 | 1.2 | 0.4 | 0.5 | 0.7 | 0.5 |
| CD34+ (×106/kg) | 5.5 | 0.4 | 5.2 | 3.6 | 18.3 | 3.6 | 7.4 | 4.7 | 1.7 | 5.3 X | 4.0 | 2.4 X |
| DEPLETION EFFICIENCY | ||||||||||||
| Yield γδ T-cells (%) | 97.2 | 84.4 | 44.2 | 101 | 31.9 | 60.2 | 36.4 | 65.1 | 70.3 | 92.9 | 76.7 | 83.5 |
| Log depl of αβ T-cells | −3.2 | −4.5 | −3.7 | −3.3 | −4.4 | −4.1 | −3.9 | −3.8 | −4.8 | −4.5 | −4.7 | −5.1 |
X
Patient 10 and 12 also received a CD34-selected product, (patient 10: 79 mL product with 86% purity; patient 12: 42 mL product with 97.0% purity), total CD34 dose for both products (αβ T-cell depleted and CD34-selected target fractions) is presented. Abbreviations: lymph, lymphocytes; TNC, total nucleated cells; depl, depletion.