A Phase I Study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory B-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 7
- 主要终点
- Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
研究概览
简要总结
This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
干预措施: FT516 (Drug)
FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
干预措施: Cyclophosphamide (Drug)
FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
干预措施: Fludarabine (Drug)
FT516 Monotherapy
FT516 monotherapy in adult subjects with r/r AML.
干预措施: IL-2 (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: FT516 (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Rituximab (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Obinutuzumab (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Cyclophosphamide (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Fludarabine (Drug)
FT516 in Combination with Monoclonal Antibodies
FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: IL-2 (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: FT516 (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Rituximab (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Obinutuzumab (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Cyclophosphamide (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Fludarabine (Drug)
FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: IL-2 (Drug)
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: FT516 (Drug)
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Rituximab (Drug)
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Obinutuzumab (Drug)
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: IL-2 (Drug)
FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
干预措施: Bendamustine (Drug)
结局指标
主要结局
Incidence, nature, and severity of AEs, of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.
时间窗: Up to 5 years
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort.
时间窗: Day 29
次要结局
- FT516 pharmacokinetic data(Cycle 1 and Cycle 2 Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, and Cycle 2 Day 43 and Cycle 2 Day 57.)
- Investigator-assessed anti-tumor activity of FT516 as monotherapy in r/r AML and in combination with rituximab or obinutuzumab in r/r B-cell lymphoma.(Cycle 2 Day 29)