CTIS2023-506820-10-00进行中（未招募）1 期
An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined with Atezolizumab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia - GO29781
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 713
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Agreement to provide tumor samples as follows: – For NHL patients with more than one bi-dimensionally measurable lesion (>1.5 cm in the largest dimension for nodal lesions, or >1.0 cm in its largest dimension for extranodal lesions by CT scan or MRI), agreement to undergo biopsy from a safely accessible site per investigator determination. Biopsies obtained at any time between the last dose of last prior anti-cancer therapy and the first dose of mosunetuzumab may be acceptable. – For patients with CLL: -Bone marrow biopsy and aspirate -Must have a circulating lymphocyte count of >5000/micro Litre blood, 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of at least 12 weeks, 3. Histologically-documented relapsed or refractory NHL or CLL expected to express the cluster of differentiation 20 (CD20) antigen and for which there is no available therapy expected to improve survival, 4. NHL patients only: must have at least one bi-dimensionally measurable lesion (>1.5 cm in its largest dimension for nodal lesions, or >1.0 cm in its largest dimension for extranodal lesions by CT or MRI scan), 5. Adequate hepatic, hematologic, and renal function
排除标准
- •1. 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 - 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 - Treatment with radiotherapy within 2 weeks prior to the first mosunetuzumab administration. - Received systemic immunosuppressive medications (with exceptions) within 2 weeks prior to first mosunetuzumab administration, 2. Prior anti-lymphoma treatment with monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates within 4 weeks before first mosunetuzumab administration Autologous SCT within 100 days prior to first mosunetuzumab administration Prior treatment with CAR-T therapy within 30 days before first mosunetuzumab administration, 3. Prior allogeneic stem cell transplantation (SCT) Prior solid organ transplantation, 4. Patients with history of macrophage activation syndrome/hemophagocytic lymphohistiocytosis or confirmed progressive multifocal leukoencephalopathy (PML), 5. History of central nervous system (CNS) lymphoma or other CNS disease, autoimmune disease, other malignancy, significant cardiovascular disease, significant active pulmonary disease, known active infection (or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to first mosunetuzumab administration), or major surgery within 4 weeks prior to first mosunetuzumab administration, 6. Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
研究者
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