Table 2.
Safety evaluation
| Patients No | The number of infusions and maximum dose | HBV TCR-T cell related AE | Best overall response | TTP (months) |
OS (months) |
Current status | |
|---|---|---|---|---|---|---|---|
| AE | Associated dose | ||||||
| B001 | 12 (5 × 106/kg) |
Grade 3 ALT increase; Grade 3 GGT increase; Grade 3 AST increase; Grade 3 bilirubin increase |
1 × 105/kg | PR | 27.7 |
37.4 (censored) |
Loss to follow-up |
| B002 | 8 (2 × 106/kg) | Grade 1 ALT increase | 5 × 104/kg | SD | 2.97 | 33.1 | Death |
| B003 | 4 (1 × 106/kg) | None | NA | PD | 0.93 | 3.53 | Death |
| B004 | 4 (2 × 105/kg) | None | NA | SD | 0.9 | 2.53 | Death |
| B005 | 4 (5 × 106/kg) | None | NA | SD | 9.4 |
18.8 (censored) |
Loss to follow-up |
| B006 | 4 (1.53 × 106/kg) | None | NA | NE | 23.8 |
23.8 (censored) |
Alive |
| B007 | 8 (5 × 106/kg) | None | NA | PD | 0.2 | 6.7 | Death |
| B008 | 8 (5 × 106/kg) | None | NA | NE | 16.9 |
20.0 (censored) |
Alive |
HBV hepatitis B virus, AE adverse reaction, TTP time-to-progression, OS overall survival, ALT alanine transaminase, GGT gamma-glutamyltransferase, AST aspartate aminotransferase, PR partial response, SD stable disease, PD progressive disease, NE not evaluated, NA not available