Table 2.
Leukapheresis, production and infusion characteristics
| Treatments* (n=91) |
ALL* (n=38) |
NHL (n=53) |
P value ALL vs NHL |
|
| Leukapheresis | ||||
| CD3 + T cells, (%) | 53.3±24.5 | 52±25.2 | 54.3±24 | 0.661 |
| CD19 + B cells, (%) | 4.6±8.8 | 7.8±10.9 | 2.3±5.9 | 0.003 |
| Production | ||||
| Cell number at initiation, (x10e6) | 402±47 | 405±72 | 400±0 | 0.620 |
| Cell number on day 2, (x10e6) | 273±193 | 304±171 | 251±205 | 0.203 |
| Cell number for transduction, (x10e6) | 59.0±10.3 | 58.2±9.5 | 59.5±10.8 | 0.555 |
| Total cell number day 6, (x10e6) | 390±289 | 475±313 | 328±254 | 0.017 |
| Fold expansion day 6† | 6.9±5.7 | 8.6±6.3 | 5.7±4.9 | 0.016 |
| CAR-T day 6, (%) | 58.7±17.4 | 64.1±15.5 | 54.8±17.6 | 0.012 |
| CAR-T cell number day 6, (x10e6) | 248±216 | 319±230 | 196±189 | 0.007 |
| CD19 + B cells day 6, (%) | 0±0.2 | 0±0.2 | 0±0.3 | 0.831 |
| Total cell number day 10, (x10e6) | 1246±949 | 1543±1104 | 1033±750 | 0.011 |
| Fold expansion day 10† | 22.4±19.7 | 28.7±24.7 | 17.8±13.5 | 0.009 |
| CAR-T cell number day 10, (x10e6) | 891±795 | 1,174±901 | 688±635 | 0.004 |
| Infusion product | ||||
| CAR-T cells, (%) | 67.1±19.1 | 73.5±16.3 | 62.6±19.6 | 0.007 |
| CD4 + CAR-T, (%) | 29±18.1 | 33±19.2 | 26.1±16.6 | 0.070 |
| CD8 + CAR-T, (%) | 71±18.1 | 67±19.2 | 73.9±16.6 | 0.071 |
| CD19 + B cells, (%) | 0±0 | 0±0 | 0±0 | 1 |
*One ALL patient was treated twice.
†Fold expansion in comparison to the number of cells taken for transduction on day 2.
ALL, acute lymphoblastic leukemia; NHL, non-Hodgkin's lymphoma.