Huberman M S, Lokich J J, Hill T, Kaldany A, Kassis A, Price T, Moore C, Davis S, Kasulis P, Monaco A P
Cancer Immunol Immunother. 1986;23(2):137-42. doi: 10.1007/BF00199820.
A total of 14 patients with advanced visceral carcinoma which produced carcinoembryonic antigen (CEA) were treated in a Phase I study with IV infusion of affinity purified baboon anti-CEA antibody (dosage range from 0.1 to 2 mg/kg body weight). In all 14 patients, the antibody infusion caused a decrease (26% to 97%) in the plasma level of CEA. The degree of decrease depended upon the patients initial CEA level and the amount of antibody given. In 12 of the 14 patients "free" circulating antibody was observed. The plasma half-life of the antibody ranged from 0.7 to 21 h and the duration of detectable free antibody ranged from 3 to 216 h postinfusion. No toxicity was observed for the dosage range of antibody tested. In 9 of the 14 patients a low titer anti-baboon antibody response occurred between 14 and 28 days postinfusion. No clinical regression of carcinoma was documented. In 7 of the 14 patients disease remained stable during the 28-day study period. By the end of the 28-day study period plasma CEA levels had returned to at least the preinfusion level in 11 of the 14 patients.
在一项I期研究中，对14例产生癌胚抗原（CEA）的晚期内脏癌患者进行了静脉输注亲和纯化的狒狒抗CEA抗体（剂量范围为0.1至2mg/kg体重）的治疗。在所有14例患者中，抗体输注导致CEA血浆水平下降（26%至97%）。下降程度取决于患者初始CEA水平和给予的抗体量。在14例患者中的12例中观察到了“游离”循环抗体。抗体的血浆半衰期为0.7至21小时，输注后可检测到游离抗体的持续时间为3至216小时。在所测试的抗体剂量范围内未观察到毒性。在14例患者中的9例中，输注后14至28天出现了低滴度抗狒狒抗体反应。未记录到癌症的临床消退。在14例患者中的7例中，疾病在28天的研究期间保持稳定。到28天研究期结束时，14例患者中的11例血浆CEA水平至少恢复到输注前水平。
