Díaz Alain, Alfonso Mauro, Alonso Ruby, Saurez Giselle, Troche Mayelín, Catalá Mauricio, Díaz Rosa María, Pérez Rolando, Vázquez Ana María
Center of Molecular Immunology, Havana, Cuba.
Clin Immunol. 2003 May;107(2):80-9. doi: 10.1016/s1521-6616(03)00036-6.
A phase I clinical trial was conducted in patients with stage III/IV breast cancer who were treated with the anti-idiotype mAb 1E10 specific to an Ab1 mAb able to react specifically with N-glycolyl-containing gangliosides and with antigens expressed on human melanoma and breast carcinoma cells. Patients were treated with 1 or 2 mg of aluminum hydroxide-precipitated 1E10 mAb every other week for six injections. Two patients at each dose were reimmunized 7-9 months after completing the induction phase. In hyperimmune sera from eight of the nine patients who received at least four doses of anti-Id vaccine preparations, strong specific responses were observed both against 1E10 mAb and NeuGc-GM3 ganglioside (Ab3 Id+Ag+). Nonclassical Ab1' antibodies (Id-Ag+) were also elicited by 1E10 mAb vaccine treatment. There were no differences between the two levels of dose tested in relation to toxicity and immunogenicity. No evidence of serious or unexpected effects was observed.
对 III/IV 期乳腺癌患者进行了一项 I 期临床试验，这些患者接受了抗独特型单克隆抗体 1E10 的治疗，该抗体针对一种 Ab1 单克隆抗体，能够与含 N-羟乙酰神经氨酸的神经节苷脂以及人黑色素瘤和乳腺癌细胞上表达的抗原发生特异性反应。患者每隔一周接受 1 或 2 毫克氢氧化铝沉淀的 1E10 单克隆抗体，共注射六次。在完成诱导期 7 - 9 个月后，对每个剂量组的两名患者进行再次免疫。在接受至少四剂抗独特型疫苗制剂的九名患者中的八名患者的超免疫血清中，观察到针对 1E10 单克隆抗体和 N-羟乙酰神经节苷脂（Ab3 Id+Ag+）的强烈特异性反应。1E10 单克隆抗体疫苗治疗还引发了非经典的 Ab1' 抗体（Id-Ag+）。在测试的两个剂量水平之间，在毒性和免疫原性方面没有差异。未观察到严重或意外影响的证据。
