CAMELLIA: Anti-CD47 Antibody Therapy in Haematological Malignancies
关键词
抽象
日期
| 最后验证: | 01/31/2019 |
| 首次提交: | 01/26/2016 |
| 提交的预估入学人数: | 02/03/2016 |
| 首次发布: | 02/08/2016 |
| 上次提交的更新: | 02/18/2019 |
| 最近更新发布: | 02/20/2019 |
| 实际学习开始日期: | 10/31/2015 |
| 预计主要完成日期: | 10/31/2018 |
| 预计完成日期: | 01/31/2019 |
状况或疾病
干预/治疗
Drug: Hu5F9-G4
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Hu5F9-G4 Dose Escalation: CD47 blocking antibody Hu5F9-G4 | Drug: Hu5F9-G4 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Key Inclusion Criteria: - Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to WHO classification, with an International Prognostic Scoring System (IPSS) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration. - Male or female, Age ≥ 18 years. - Eastern Cooperative Oncology Group (ECOG) performance score of 0‐1 - Willing to undergo blood transfusions as deemed clinically necessary. - Adequate hematological, liver, and kidney function Key Exclusion Criteria: - Females: Pregnant or breast‐feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. Males: unless an effective method of contraception is used during and for 3 months after the trial. - Any prior exposure to Hu5F9‐G4 or other CD47 targeting agents. - Treatment with any other investigational agent within 28 days prior to enrolment. - Previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression - Evidence for active CNS involvement by leukaemia - Clinical evidence or known history of cardiopulmonary disease |
结果
主要结果指标
1. Maximum tolerated dose (MTD) of Hu5F9‐G4, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Part A) [Up to 28 days]
