表3. 重组人-鼠嵌合抗CD20单抗IBI301Ⅰ期剂量递增试验给药后不同时间受试者IgG、IgM水平.
例号 | IBI301剂量 | IgG(g/L) |
IgM (g/L) |
||||||||
0 da | 8 d | 29 d | 57 d | 85 d | 0 da | 8 d | 29 d | 57 d | 85 d | ||
1 | 125 mg/m2 | 12.4 | 12.3 | 13.1 | 12.9 | 14.2 | 0.34 | 0.30 | 0.37 | 0.30 | 0.32 |
2 | 125 mg/m2 | 12.3 | 12.3 | 14.5 | 13.7 | 14.2 | 0.36 | 0.40 | 0.46 | 0.47 | 0.45 |
3 | 125 mg/m2 | 8.3 | 7.3 | 7.8 | 8.2 | 8.1 | 0.31 | 0.27 | 0.28 | 0.28 | 0.26 |
4 | 375 mg/m2 | 10.7 | 10.9 | 11.3 | 10.7 | 9.9 | 0.37 | 0.43 | 0.38 | 0.34 | 0.30 |
5 | 375 mg/m2 | 7.7 | 6.9 | 7.8 | 8.1 | 7.6 | 0.55 | 0.51 | 0.58 | 0.63 | 0.57 |
6 | 375 mg/m2 | 14.7 | 13.1 | 15.2 | 15.4 | 15.1 | 0.88 | 0.92 | 0.94 | 0.88 | 0.80 |
7 | 500 mg/m2 | 7.6 | 7.5 | 7.6 | 8.3 | 8.3 | 0.37 | 0.35 | 0.38 | 0.30 | 0.33 |
8 | 500 mg/m2 | 9.1 | 8.7 | 8.4 | 7.8 | 7.4 | 0.30 | 0.28 | 0.28 | 0.23 | 0.19 |
9 | 500 mg/m2 | 9.5 | 8.4 | 9.4 | 9.7 | 10.1 | 0.51 | 0.41 | 0.33 | 0.25 | 0.13 |
注:a:治疗前