ISRCTN49178226进行中（未招募）1 期
An open-label, multicenter, Phase I trial evaluating the pharmacokinetics, safety, and efficacy of mosunetuzumab as a single agent in patients with relapsed or refractory follicular lymphoma
Roche (Switzerland)0 个研究点目标入组 17 人开始时间: 2021年12月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years at the time of signing Informed Consent Form (ICF)
- •2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •3. Histologically confirmed Grade 1-3a follicular lymphoma who have relapsed after or failed to respond to at least two prior lines of systemic therapy and must have received prior treatment with an anti-CD20-directed therapy and an alkylating agent
- •4. Participants must have a measurable disease: at least one bi-dimensionally measurable lesion (greater than 1.5 cm in its largest dimension for nodal lesions, or greater than 1.0 cm in its largest dimension for extranodal lesions)
- •5. Fluorodeoxyglucose (FDG)-avid lymphoma [i.e., positron emission tomography (PET) - positive lymphoma]
- •6. Adverse events from prior anti-cancer therapy resolved to = Grade 1 (with exceptions of alopecia and anorexia)
- •7. Residence in the People’s Republic of China
排除标准
- •1. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)
- •2. Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before the first mosunetuzumab administration
- •3. Prior treatment with systemic immunotherapeutic agents for which the mechanism of action involves T cells within 12 weeks or five half-lives of the drug, whichever is shorter, before first Mosunetuzumab administration
- •4. Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents (e.g., immune checkpoint inhibitor therapies)
- •5. Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first mosunetuzumab administration
- •6. Treatment with radiotherapy within 2 weeks prior to the first mosunetuzumab administration
- •7. Autologous stem cell transplant (SCT) within 100 days prior to first mosunetuzumab administration
- •8. Prior treatment with CAR-T therapy within 30 days before first Mosunetuzumab administration
- •9. Prior allogeneic SCT
- •10. Prior solid organ transplantation
- •11. History of autoimmune disease but participants with a remote history of, or well-controlled autoimmune disease may be eligible to enrol
- •12. Participants with a history of macrophage activation syndrome (MAS)/hemophagocytic lymphohistiocytosis (HLH)
- •13. Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
- •14. Current or past history of CNS lymphoma
- •15. Known or suspected chronic active Epstein-Barr Virus infection (CAEBV)
研究者
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