Table 1.
Release Criteria of the Good Manufacturing Practice–Grade Cell Products
| Item | Specification | NKITCR001 | NKITCR002 | NKITCR003 |
|---|---|---|---|---|
| Transduction efficiencya | ≥10% 1D3 TCR+ of CD3+ cells | 20%b | 84% | 65% |
| Microbiological contamination | Negative (48–96 hr before infusion) | Negative | Negative | Negative |
| Transduced cell numberc | 2.5×108–2.5×10101D3 TCR+ CD3+ cells | 3.3×109 | 1.5×109 | 3.4×109 |
| Cell viability | >70% | 97% | 93% | 98% |
TCR, T-cell receptor.
a
Transduction efficiency measured on day 3 posttransduction.
b
Transduction only performed once.
c
The minimum and maximum amount of TCR-transduced cells that will be infused.