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PHASE I/IB TRIAL OF HU14 18 IL 2 FUSION PROTEIN IN PATIENTS W/ GD2+ T

PHASE I/IB TRIAL OF HU14 18 IL 2 FUSION PROTEIN IN PATIENTS W/ GD2+ T
HU14 18 IL 2 融合蛋白在 GD2 T 患者中的 I/IB 期试验
批准号：
6265755
负责人：
MARK R ALBERTINI
金额：
$3.35万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6265755
关键词：
chimeric proteins clinical research clinical trial phase I human subject human therapy evaluation interleukin 2 melanoma neoplasm /cancer immunotherapy

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中文摘要
翻译
这是一项针对黑色素瘤、肉瘤和神经母细胞瘤表面发现的GD2神经节苷脂的改进的14.18抗体的I期试验。“人源化”抗体预计会产生减弱的HAMA反应；IL-2的目的是吸引和刺激细胞毒性T细胞摧毁“标记的”细胞。GD2+肿瘤的患者将接受为期三天的四小时静脉输注融合蛋白，从每天1毫克/平方米/天开始。随后的N=1队列将接受2、4、6和9 mg/m2/天的治疗。然后，分两个阶段的设计将以三人为一组，探索MTD。
英文摘要
This is a Phase I trial of an improved 14.18 antibody linked to IL-2 and directed against the GD2 ganglioside found on the surface of melanomas, sarcomas, and neuroblastomas. The "humanized" antibody is expected to yield a diminished HAMA response; the IL-2 is intended to attract and stimulate cytotoxic T cells to destroy the "labeled" cells. Patients with GD2+ tumors will receive three-day cycles of four hour intravenous infusions of the fusion protein, starting at a daily dose of 1 mg/m2/day. Subsequent cohorts of N=1 will be treated at 2, 4, 6 and 9 mg/m2/day. The two-stage design will then explore the MTD in cohorts of three.
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