A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 98
- 试验地点
- 9
- 主要终点
- Incidence of dose-limiting toxicities within each dose level cohort
研究概览
简要总结
This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. 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
- Non Randomized
- 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
- •Diagnosis of B-cell lymphoma or CLL as described below:
- •B-Cell Lymphoma:
- •Histologically documented lymphomas expected to express CD19 and CD20
- •Relapsed/refractory disease following prior systemic immunochemotherapy regimen
- •Chronic Lymphocytic Leukemia (CLL):
- •Diagnosis of CLL per iwCLL guidelines
- •Relapsed/refractory disease following at least two prior systemic treatment regimens
- •ALL SUBJECTS:
- •Capable of giving signed informed consent
- •Age ≥ 18 years old
- •Stated willingness to comply with study procedures and duration
- •Contraceptive use for women and men as defined in the protocol
排除标准
- •ALL SUBJECTS:
- •Females who are pregnant or breastfeeding
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
- •Body weight <50 kg
- •Evidence of insufficient organ function
- •Receipt 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
- •Currently receiving or likely to require systemic immunosuppressive therapy
- •Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
- •Receipt of an allograft organ transplant
- •Known active central nervous system (CNS) involvement by malignancy
- •Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- •Clinically significant cardiovascular disease
- •Known HIV infection
- •Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
- •Live vaccine <6 weeks prior to start of lympho-conditioning
- •Known allergy to albumin (human) or DMSO
研究组 & 干预措施
FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: FT596 (Drug)
FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT596 Monotherapy, Lymphoma
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
干预措施: FT596 (Drug)
FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
干预措施: Rituximab (Drug)
FT596 in Combination with Rituximab, Lymphoma
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
干预措施: FT596 (Drug)
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
干预措施: Obinutuzumab (Drug)
FT596 in Combination with Obinutuzumab, Lymphoma
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
干预措施: FT596 (Drug)
FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT596 Monotherapy, CLL
FT596 monotherapy in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
干预措施: FT596 (Drug)
FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
干预措施: Obinutuzumab (Drug)
FT596 in Combination with Obinutuzumab, CLL
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities within each dose level cohort
时间窗: Day 29
Nature of dose-limiting toxicities within each dose level cohort
时间窗: Day 29
Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0
时间窗: Up to 15 years
次要结局
- Investigator-assessed objective-response rate (ORR)(From baseline tumor assessment up to approximately 2 years after last dose of FT596)
- Investigator-assessed duration of objective response (DOR)(Up to 15 years)
- Investigator-assessed duration of complete response (DoCR)(Up to 15 years)
- Progression-free survival (PFS)(Up to 15 years)
- Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.(Up to 15 years)
- The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points(Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29)