Characterization of infused products
| Criteria . | Case 1* . | Case 2 . |
|---|---|---|
| No. of cells infused | 10.00E+09 | 5.09E+09 |
| % Transduction efficiency | 52.80% | 47.50% |
| No. of transduced cells | 5.28E+09 | 2.42E+09 |
| Viability of sentinel vial | 93.60% | 88.90% |
| % CD3+CD45+ | 98.20% | 99% |
| % CD4 of CD3 | 53.80% | 60.40% |
| % CD8 of CD3 | 45.60% | 39.70% |
| % CD62L+ of CD3 | 97.6% | 94.1% |
| Transduction efficiency via vector copy number | 1.17 copy/cell | 0.8 copy/cell |
| Criteria . | Case 1* . | Case 2 . |
|---|---|---|
| No. of cells infused | 10.00E+09 | 5.09E+09 |
| % Transduction efficiency | 52.80% | 47.50% |
| No. of transduced cells | 5.28E+09 | 2.42E+09 |
| Viability of sentinel vial | 93.60% | 88.90% |
| % CD3+CD45+ | 98.20% | 99% |
| % CD4 of CD3 | 53.80% | 60.40% |
| % CD8 of CD3 | 45.60% | 39.70% |
| % CD62L+ of CD3 | 97.6% | 94.1% |
| Transduction efficiency via vector copy number | 1.17 copy/cell | 0.8 copy/cell |
As per protocol, Case 1 was infused by using a split-dose regimen with 30% and 70% of the dose infused on day +5 and day +6, respectively.