A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
研究概览
简要总结
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab
- •Capable of giving signed informed consent
- •Aged ≥ 18 years old
- •Willingness to comply with study procedures and duration
- •Measurable disease per iRECIST
- •Contraceptive use for women and men as defined in the protocol
排除标准
- •Pregnant or breast-feeding women
- •ECOG performance status ≥ 2
- •Evidence of insufficient organ function
- •Clinically significant cardiovascular disease
- •Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
- •Known active central nervous system (CNS) involvement by malignancy
- •Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
- •Currently receiving or likely to require immunosuppressive therapy
- •Known active infections with Hepatitis B, Hepatitis C or HIV
- •Live vaccine within 6 weeks prior to start of lympho-conditioning
- •Known allergy to albumin (human) or DMSO
研究组 & 干预措施
FT516 in combination with avelumab
干预措施: IL-2 (Drug)
FT516 in combination with avelumab
干预措施: FT516 (Drug)
FT516 in combination with avelumab
干预措施: Avelumab (Drug)
FT516 in combination with avelumab
干预措施: Cyclophosphamide (Drug)
FT516 in combination with avelumab
干预措施: Fludarabine (Drug)
结局指标
主要结局
Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
时间窗: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
The incidence of DLTs within each dose level cohort will be reported. A DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
Severity of DLTs Within Each Dose Level Cohort
时间窗: At the end of Cycle 1 (each cycle is 28 days)
The severity of DLTs within each cohort will be reported. DLT is any adverse event (AE) that is at least possibly related to FT516 that occurs after the first FT516 infusion through the end of the DLT assessment period on Cycle 1 Day 29, and meets 1 of the criteria from the NCI CTCAE v5.0 or the ASTCT Consensus Grading Guidelines for Cytokine Release Syndrome and Neurological Toxicity Associated with Immune Effector Cells.
次要结局
- Overall Survival (OS)(Up to 15 years)
- Number of Participants with ≥1 Adverse Events (AE)(Up to 15 years)
- Investigator-Assessed Duration of Response (DOR)(Up to 15 years)
- Disease Control Rate (DCR)(Up to 15 years)
- Progression Free Survival (PFS)(Up to 15 years)
- Determination of PK of FT516 in peripheral blood(Study Days 1, 2, 4, 8, 11, 18, 22, 29)