CLINICAL TRIAL: SGN-40 (ANTI-HUCD40 MAB) IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA

临床试验：SGN-40（抗 HUCD40 MAB）在非霍奇金淋巴瘤患者中的应用

• 批准号: 7717874
• 负责人: RAJ ADVANI
• 金额: $ 0.08万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717874
• 关键词: Adult; Affect; Age; Antigens; B lymphoid malignancy; B-Lymphocytes; Blood; Blood Vessels; Bone Marrow; Cell surface; Chemotherapy-Oncologic Procedure; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Dendritic Cells; Disease; Dose; Dose-Limiting; End Point; Endothelial Cells; Epithelial Cells; Funding; Goals; Grant; Human; Incidence; Indolent; Institution; Lymphocyte; Lymphoma; Malignant Neoplasms; Mature B-Lymphocyte; Maximum Tolerated Dose; Monoclonal Antibodies; Nervous system structure; Non-Hodgkin' s Lymphoma; Organ; Patients; Phase I Clinical Trials; Prevalence; Radiation therapy; Rate; Relapse; Research; Research Personnel; Resources; Safety; Source; Spleen; Staging; Stem cell transplant; TNFRSF5 gene; Toxic effect; Tumor Necrosis Factor-alpha; Tumor Necrosis Factors; United States; United States National Institutes of Health; chemotherapy; human TNF protein; lymph nodes; lymphocyte proliferation; member; monocyte; novel; prognostic; receptor; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: The objectives of this Phase I study with patients with non-Hodgkin's lymphoma (NHL) are: 1. To define the safety profile of 4 weekly doses of an anti-human CD40 monoclonal antibody, SGN-40 2. To determine the maximum tolerated dose of 4 weekly doses of SGN 3. To obtain preliminary anti-tumor activity of SGN-40 Goals: NHL is a heterogeneous malignancy originating from lymphocytes. In the United States, the incidence is estimated at about 54,000/yr with a prevalence of approximately 331,000. The majority (80%) of lymphoma cases is of B-cell origin. While the disease can occur in all ages, the incidence increases with age, with the usual onset beginning in adults over 40 years. NHL is characterized by a clonal proliferation of lymphocytes that accumulate in the lymph nodes, blood, bone marrow, and spleen, although any major organ may be involved. NHL can be divided into two prognostic groups: indolent and aggressive. Intensive combination chemotherapy regimens cure some cases of the aggressive forms of NHL. The more indolent and follicular forms of the disease that affect nearly half of all patients with NHL are considered incurable. While indolent NHL is responsive to radiation therapy and chemotherapy, a continuous rate of relapse is usually seen in advanced stages. In patients who have relapsed from primary treatment and who are not candidates for stem cell transplantation, novel therapies that can provide clinical benefit are needed. The expression of CD40, a member of the tumor necrosis factor (TNF) superfamily, on aggressive NHL makes this antigen an attractive target for treatment of relapsed patients. CD40 is a receptor molecule on the cell surface of all mature B cells (B lymphocytes), most B-cell malignancies, monocytes, dendritic cells (in the nervous system), endothelial cells (within blood vessels), and epithelial cells. Endpoints: This is a Phase I study, and as such endpoints will include: + Defining the safety profile [dose limiting toxicity (DLT)] of 4 weekly doses of SGN-40 in patients with NHL + Determining the maximum tolerated dose (MTD) of 4 weekly doses of SGN-40 in patients with NHL + Obtaining preliminary anti-tumor activity of SGN-40 in patients with NHL

这个子项目是众多研究子项目之一