NCT01138579撤回1 期
Phase I/II Dose-escalation Study of the Investigational Trifunctional Bispecific Anti-CD20 x Anti-CD3 Antibody FBTA05 in Combination With Donor Lymphocyte Infusion (DLI) in Patients With CD20 Positive Chronic Lymphocytic Leukemia (CLL), Low and High Grade Non-Hodgkin´s Lymphoma (NHL) After Allogeneic Stem Cell Transplantation
Technical University of Munich1 个研究点 分布在 1 个国家开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Phase I: Determination of the maximum tolerated dose (MTD)
研究概览
简要总结
This study is an investigator driven, open-label, non-randomized, uncontrolled, dose escalating Phase I/II study evaluating the safety and preliminary efficacy of the trifunctional bispecific antibody FBTA05 in combination with donor lymphocyte infusions (DLI) for treatment of relapsed or refractory disease in CD20 positive either low- or high-grade non-Hodgkin´s lymphoma after allogeneic transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient´s written informed consent
- •≥ 18 years of age; male and female
- •Confirmed CLL, low grade NHL or high grade NHL on standard histological or immunophenotypical criteria described in the WHO classification of lymphoid malignancies
- •CD20 positivity (if not already confirmed)
- •Adequate haematological, liver and kidney functions
- •Platelet count ≥25,000mm³ (=25 x 10^9/l)
- •Patients with active disease (relapsed/refractory) that survived at least 60 days after allogeneic transplantation
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Appendix IV)
- •Negative pregnancy test (no more than 2 days before enrolment) and adequate contraception during the study in women of child bearing potential (pre- menopausal, <2 years post-menopausal or not surgically sterile)
排除标准
- •Any anti-CD20 and / or any other anti-T cell directed antibody treatments < 3 months before application of FBTA05
- •Positivity for human anti-mouse antibodies (HAMAs)
- •History of GvHD ° III or IV, or GvHD requiring steroid therapy with more than 10 mg/day
- •Known or suspected hypersensitivity to recombinant, murine or rat proteins
- •AST/SGOT greater than 10 x ULN (grade 3, CTCAE)
- •Bilirubin greater than 5 x ULN (grade 3, CTCAE)
- •Creatinine greater than 3.5 mg/dl (grade 3, CTCAE)
- •Acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g.HCV, HBV, HIV)
- •Unable or unwilling to comply fully with the protocol
- •Any condition which in the judgement of the Investigator would place the subject at undue risk or interfere with the results of the study
研究组 & 干预措施
1
Experimental
干预措施: FBTA05 (Drug)
结局指标
主要结局
Phase I: Determination of the maximum tolerated dose (MTD)
Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI
次要结局
未报告次要终点
研究者
研究点 (1)
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