A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Nature of dose-limiting toxicities within each dose escalation cohort
研究概览
简要总结
This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.
详细描述
This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.
Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.
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 B-cell lymphoma (BCL) as described below:
- •Histologically documented BCL
- •Previously untreated or no more than one prior systemic therapy for BCL
- •At least one bi-dimensionally measurable lesion
- •Subjects with >1 measurable lesion agreement to undergo a biopsy
- •Capable of giving signed informed consent
- •Age ≥ 18 years old
- •Stated willingness to comply with study procedures through study duration
- •Contraception use for women and men as defined in the protocol
- •Negative serum pregnancy test within 7 days of treatment for women
排除标准
- •Prior anthracycline therapy
- •Females who are pregnant or breastfeeding
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
- •Evidence of insufficient organ function
- •Currently receiving or likely to receive systemic immunosuppressive therapy
- •Receipt of 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 HIV test
- •Positive Hepatitis B (HBV) or Hepatitis C (HCV) test
- •Live vaccine <6 weeks prior to start of conditioning
- •Allergy to human albumin or dimethyl sulfoxide (DMSO)
研究组 & 干预措施
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: FT596 (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Cyclophosphamide (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Doxorubicin (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Vincristine (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Prednisone (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Rituximab (Drug)
Regimen A (FT596 in combination with standard schedule R-CHOP)
FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
干预措施: Bendamustine (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: FT596 (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Cyclophosphamide (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Doxorubicin (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Vincristine (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Prednisone (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Rituximab (Drug)
Regimen B (FT596 in combination with alternate schedule R-CHOP)
FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
干预措施: Bendamustine (Drug)
结局指标
主要结局
Nature of dose-limiting toxicities within each dose escalation cohort
时间窗: Day 21
Incidence of dose-limiting toxicities within each dose escalation cohort
时间窗: Day 21
Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0
时间窗: Up to 5 years
次要结局
- Investigator-assessed complete response (CR)(Up to 2 years)
- Investigator-assessed duration of response (DOR)(Up to 15 years)
- Investigator-assessed objective-response rate (ORR)(Up to 2 years)
- Investigator-assessed duration of complete response (DoCR)(Up to 15 years)
- Progression-free survival (PFS)(Up to 15 years)
- Overall survival (OS)(Up to 15 years)
- Area Under the Plasma Concentration Time Curve (AUC) of FT596(Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8)
- Maximum Plasma Concentration (Cmax) of FT596(Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8)