A Phase I Study of FT819 in Subjects With B-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 18
- 主要终点
- Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
研究概览
简要总结
This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic 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, CLL or B-ALL as described below:
- •B-Cell Lymphoma:
- •Histologically documented lymphomas expected to express CD19
- •Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy
- •Chronic Lymphocytic Leukemia (CLL):
- •Diagnosis of CLL per iwCLL guidelines
- •Relapsed/refractory disease following at least two prior systemic treatment regimens
- •Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):
- •Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
- •Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen
- •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 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
- •Currently receiving or likely to require systemic immunosuppressive therapy
- •Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
- •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
- •Positive serologic test results for HIV infection
- •Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
- •Positive serologic and PCR test results for 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
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: FT819 (Drug)
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: FT819 (Drug)
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: IL-2 (Drug)
FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
干预措施: FT819 (Drug)
FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
干预措施: FT819 (Drug)
FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
干预措施: FT819 (Drug)
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
干预措施: IL-2 (Drug)
FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
干预措施: FT819 (Drug)
FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
干预措施: FT819 (Drug)
FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
干预措施: Cyclophosphamide (Drug)
FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
干预措施: Fludarabine (Drug)
FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
干预措施: Bendamustine (Drug)
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: FT819 (Drug)
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Cyclophosphamide (Drug)
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Fludarabine (Drug)
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: IL-2 (Drug)
FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
干预措施: FT819 (Drug)
FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: FT819 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: IL-2 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
干预措施: Bendamustine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
干预措施: FT819 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
干预措施: IL-2 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: FT819 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Cyclophosphamide (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Fludarabine (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: IL-2 (Drug)
FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
干预措施: Bendamustine (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
时间窗: Up to 15 years
Incidence and nature of dose-limiting toxicities within each dose level cohort
时间窗: Up to Day 29
次要结局
- Overall survival (OS)(Up to 15 years)
- Investigator-assessed objective-response rate (ORR)(Up to approximately 2 years after last dose of FT819)
- For B-ALL Only: Investigator-assessed relapse-free survival (RFS)(Up to 15 years)
- Determination of the pharmacokinetics of FT819 cells in peripheral blood.(Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29)
- For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)(Up to 15 years)
- For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)(Up to 15 years)
- For BCL and CLL Only: Progression-free survival (PFS)(Up to 15 years)