PHASE I/II - CLINICAL EVALUATION OF BIOLOGICAL RESPONSE

独立，而不是作为联邦政府的代理人，这位大师 协议(MA)持有者应进行生物学临床试验 响应修改器(BRM)符合经 国家癌症研究所(NCI)，这些报告是为了回应 根据金融管理专员发出的个别主协议命令(MAO)。每一位毛 将需要至少一次这样的临床试验的表现。在……里面 执行此类协议时，MA持有者应提供所有服务， 合格的人员、材料、设备和设施 由政府根据毛主席的条款提供。 根据MAO的具体要求，临床方案 将需要研究任何数量的BRM，包括单克隆 抗体及相关结构、细胞因子、生长/分化 因子、肿瘤疫苗、细胞过继转移、基因转移、 抗转移药物、抗癌基因药物或下列药物的某种组合 这些。每项议定书的目标应包括毒性评估 治疗方案，探索抗肿瘤作用机制， 观察抗肿瘤反应，并测定其特异性 适用于该方案的实验室参数。协议应为 由NCI正式批准，并由NCI临床试验监测 监控服务。MA持有者应遵守所有联邦 对实验药物的临床试验的法规要求。

Independently and not as an agent of the Federal Government, this Master Agreement (MA) holder shall conduct clinical trials of biological response modifiers (BRMs) in accordance with protocols approved by the National Cancer Institute (NCI), which are submitted in response to individual Master Agreement Orders (MAOs) issued under the MA. Each MAO will entail the performance of at least one such clinical trial. In conducting such protocols, the MA holder shall furnish all services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government under the terms of the MAO. Depending upon the specific requirements of the MAO, clinical protocols shall entail study of any of a number of BRMs, including monoclonal antibodies and related constructs, cytokines, growth/differentiation factors, tumor vaccines, adoptive transfer of cells, gene transfer, anti-metastatic agents, anti-oncogene agents, or some combination of these. Objectives of each protocol shall include assessment of toxicity of the treatment regimen, exploration of mechanisms of antitumor action, observation of antitumor responses, and measurement of specific laboratory parameters appropriate for that protocol. Protocols shall be formally approved by the NCI, and monitored by the NCI's Clinical Trial Monitoring Service. The MA holder shall comply with all federal regulatory requirements for clinical trials of experimental agents.