NCT04614636终止1 期
A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 8
- 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 I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). 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
- 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
- •Diagnosis of one of the following by treatment regimen:
- •Regimen A (FT538 monotherapy in r/r AML)
- •Primary refractory AML, or
- •Relapsed AML, defined as not in CR after one or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required
- •Regimens B or C (FT538 + mAb in r/r MM)
- •Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
- •Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
- •Regimen B and Regimen C: Measurable disease as defined in the protocol
- •Capable of giving signed informed consent
- •Agreement to comply with study procedures as described in the Schedule of Activities
- •Agrees to contraceptive use as described in the protocol
排除标准
- •Females who are pregnant or breastfeeding
- •ECOG Performance Status ≥ 2
- •Evidence of insufficient hematologic function as defined in the protocol
- •Evidence of insufficient organ function defined as defined by the protocol
- •Clinically significant cardiovascular disease as defined by the protocol
- •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 in the 2-year period leading up to study enrollment
- •Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
- •Clinically significant infections including HIV, HBV and HCV
- •Live vaccine <6 weeks prior to start of lympho-conditioning
- •Receipt of an allograft organ transplant
- •Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
- •Known allergy to albumin (human) or DMSO
- •Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
- •Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results
- •Exclusion Criteria Specific to Regimen A (r/r AML)
- •Diagnosis of promyelocytic leukemia with t(15;17) translocation
- •Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, 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
- •Exclusion Criteria Specific to Regimens B and C (r/r MM)
- •Plasma cell leukemia defined as a plasma cell count >2000/mm3
- •Leptomeningeal involvement of MM
- •Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb
- •Allergy or hypersensitivity to antibodies or antibody-related proteins
研究组 & 干预措施
FT538 Monotherapy
Experimental
FT538 monotherapy in subjects with r/r AML
干预措施: FT538 (Drug)
FT538 Monotherapy
Experimental
FT538 monotherapy in subjects with r/r AML
干预措施: Cyclophosphamide (Drug)
FT538 Monotherapy
Experimental
FT538 monotherapy in subjects with r/r AML
干预措施: Fludarabine (Drug)
FT538 in Combination with Daratumumab
Experimental
FT538 in combination with daratumumab in subjects with r/r MM
干预措施: FT538 (Drug)
FT538 in Combination with Daratumumab
Experimental
FT538 in combination with daratumumab in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
FT538 in Combination with Daratumumab
Experimental
FT538 in combination with daratumumab in subjects with r/r MM
干预措施: Fludarabine (Drug)
FT538 in Combination with Daratumumab
Experimental
FT538 in combination with daratumumab in subjects with r/r MM
干预措施: Daratumumab (Drug)
FT538 in Combination with Elotuzumab
Experimental
FT538 in combination with elotuzumab in subjects with r/r MM
干预措施: FT538 (Drug)
FT538 in Combination with Elotuzumab
Experimental
FT538 in combination with elotuzumab in subjects with r/r MM
干预措施: Cyclophosphamide (Drug)
FT538 in Combination with Elotuzumab
Experimental
FT538 in combination with elotuzumab in subjects with r/r MM
干预措施: Fludarabine (Drug)
FT538 in Combination with Elotuzumab
Experimental
FT538 in combination with elotuzumab in subjects with r/r MM
干预措施: Elotuzumab (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) within each dose level cohort
时间窗: Cycle 1, Up to Day 29
Nature of dose-limiting toxicities within each dose level cohort
时间窗: Cycle 1, Up to Day 29
次要结局
- Progression-free survival (PFS) of FT538 in combination with daratumumab or elotuzumab in r/r MM(Up to 15 years)
- Determination of the pharmacokinetics (PK) of FT538 cells in peripheral blood(Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29)
- Incidence, nature, and severity of adverse events (AEs) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r multiple myeloma(Up to 5 years)
- Objective response rate (ORR) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM(From baseline tumor assessment up to approximately 2 years after last dose of FT538)
- Relapse-free survival (RFS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM(Up to 15 years)
- Duration of response (DOR) of FT538 in combination with daratumumab or elotuzumab in r/r MM(Up to 15 years)
- Overall survival (OS) of FT538 as monotherapy in r/r AML and in combination with daratumumab or elotuzumab in r/r MM(Up to 15 years)
- Event-free survival (EFS) of FT538 as monotherapy in r/r AML(Up to 15 years)
- Time-to-best response of FT538 as monotherapy in r/r AML(Up to 15 years)
研究者
研究点 (8)
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