Table 2.
Characteristics of CAR-T products.
| Specification | Patient 1 | Patient 2 | |
|---|---|---|---|
| Mycoplasma | Negative | Negative | Negative |
| Sterility (bacterial)a | Negative | Negative | Negative |
| Endotoxin (EU/mL)a | <3.5 | <0.1 | <0.1 |
| CD3+% | >90% | 99% | 97.00% |
| CAR+ in CD3+% | >20% | 71.20% | 46.60% |
| CD4+ in CAR-T% | N/A | 58.90% | 26.80% |
| CD8+ in CAR-T% | N/A | 39.00% | 70.00% |
| TSCM in CAR-T% | N/A | <0.1% | 58.09% |
| TCM in CAR-T% | N/A | 97.40% | 18.60% |
| CAR T cells/kg × 106 | N/A | 4 | 3 |
| CD8/CD4 CAR-T cell ratio | N/A | 0.68 | 2.7 |
| T cell expansion fold | N/A | 350 | 500 |
| Cancer cell killing activity | E: T = 5:1 | 92 ± 2.9% | 92 ± 2.3% |
| Cell viability before transfection | >90% | 97 ± 0.3% | 98 ± 0.5% |
| Cell viability after transfection | >90% | 98 ± 0.5% | 96 ± 0.67% |
| Manufacturing time (days) | N/A | 11 | 10 |
a
Results were not available at the time of infusion. E: T effect cell (CAR-T/Mock T): target cell (MM1S).