A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

开始日期2008-08-01

申办/合作机构

Bristol Myers Squibb Co.

NCT00639834 / Completed临床1期

A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.

开始日期2008-02-01

申办/合作机构

Bristol Myers Squibb Co.

100 项与 MDX-1342 相关的临床结果

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100 项与 MDX-1342 相关的转化医学

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100 项与 MDX-1342 相关的专利（医药）

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项与 MDX-1342 相关的文献（医药）

2010-02-01·Cancer Immunology, Immunotherapy2区 · 医学

A nonfucosylated human antibody to CD19 with potent B-cell depletive activity for therapy of B-cell malignancies

2区 · 医学

Article

作者: Diann Blanset ; Haichun Huang ; Amie Pham ; Michelle R. Kuhne ; Chin Pan ; Chetana Rao-Naik ; Ben Preston ; David Passmore ; David J. King ; Jie Liu ; Maria-Cristina Moldovan-Loomis ; Alison Witte ; Sharline Chen ; Pina M. Cardarelli

A human anti-CD19 antibody was expressed in fucosyltransferase-deficient CHO cells to generate nonfucosylated MDX-1342. Binding of MDX-1342 to human CD19-expressing cells was similar to its fucosylated parental antibody. However, MDX-1342 exhibited increased affinity for FcγRIIIa-Phe158 and FcγRIIIa-Val158 receptors as well as enhanced effector cell function, as demonstrated by increased potency and efficacy in antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis assays. MDX-1342 showed dose-dependent improvement in survival using a murine B-cell lymphoma model in which Ramos cells were administered systemically. In addition, low nanomolar binding to cynomolgus monkey CD19 and increased affinity for cynomolgus monkey FcγRIIIa was observed. In vivo administration of MDX-1342 in cynomolgus monkeys revealed potent B-cell depletion, suggesting its potential utility as a B-lymphocyte depletive therapy for malignancies and autoimmune indications.

100 项与 MDX-1342 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
CD19阳性B细胞慢性淋巴细胞白血病	临床1期	美国	Bristol Myers Squibb Co.	2008-08-01
类风湿关节炎	临床1期	美国	Bristol Myers Squibb Co.	2008-02-01
类风湿关节炎	临床1期	乌克兰	Bristol Myers Squibb Co.	2008-02-01
类风湿关节炎	临床1期	德国	Bristol Myers Squibb Co.	2008-02-01
类风湿关节炎	临床1期	匈牙利	Bristol Myers Squibb Co.	2008-02-01
类风湿关节炎	临床1期	英国	Bristol Myers Squibb Co.	2008-02-01