FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Dose Limiting Toxicity Events
研究概览
简要总结
This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
详细描述
This study uses a single dose of the investigational product FT596 in the early post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®, Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to 1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and 2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant starting at one dose level below the MTD identified at Day 30.
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 diffuse large B cell lymphoma or aggressive (high-grade) B-cell lymphoma for which an autologous stem cell transplant is planned or recently completed
- •High risk for relapse defined as at least one of the below:
- •Primary induction failure (no complete or partial remission at any point after diagnosis
- •Initial remission duration < 12 months
- •Lack of complete metabolic (PET scan) response after 2-3 cycles of salvage chemotherapy
- •Evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit lymphoma)
- •Age-adjusted IPI 2-3 at relapse
- •Age 18 years or older at the time of signing consent.
- •Agrees to use adequate contraception (or evidence of sterility) for at least 12 months after the last dose of rituximab.
- •Agrees and signs the separate consent for up to 15 years of follow-up (Long-term Follow-up study CPRC#2020LS052)
- •Provides voluntary written consent prior to the performance of any research related activities.
排除标准
- •Receipt of any investigational therapy within 28 days prior to the first dose of FT596 or planned use of an investigational therapy during the first 100 days after transplant
- •Planned post-transplant irradiation prior to Day +100
- •Seropositive for HIV, active Hepatitis B or C infection with detectable viral load by PCR
- •Body weight <50kg
- •Known allergy to the following FT596 components: albumin (human) or DMSO
- •Unable to receive rituximab
- •Post-HSCT Reconfirmation of eligibility
- •No life-threatening medical issues (i.e. ongoing Grade 4 adverse events) where, in the opinion of the treating investigator, use of FT596 is not in the patient's best interest.
- •No active uncontrolled infection.
- •Adequate organ function post-transplant including:
- •alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x ULN (Grade 2 CTCAE v5)
- •total bilirubin ≤1.5 x ULN (Grade 1 CTCAE v5)
- •serum creatinine ≤1.5 x ULN (Grade 1 CTCAE v5)
- •oxygen saturation ≥93% on room air
- •For Day 30 dosing only - CBC requirement consistent with engraftment (ANC>500, platelet>20,000 without transfusion support within previous 7 days). There are no CBC parameters for Day 7 dosing.
- •No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during the FT596 dosing period.
研究组 & 干预措施
FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: FT596 (Drug)
FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: Rituximab (Drug)
FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: FT596 (Drug)
FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: Rituximab (Drug)
FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: FT596 (Drug)
FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose
Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants Experiencing Dose Limiting Toxicity Events
时间窗: 28 Days Post FT596 infusion
The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours
次要结局
- Progression-Free Survival 12 Months Post Auto-HCT(12 Months Post Auto-HCT)
- Number of Participants Experiencing Adverse Events(1 year post FT596 infusion)
- Percentage of Participants With Relapse/Progression(1 year post auto HSCT)
- Number of Participants Experiencing Non-relapse Mortality Incidents at 100 Days Post HSCT(100 days post HSCT)
- Percentage of Non-relapse Mortality Incidents at One Year Post HSCT(one year post auto-HSCT)