UW26004: Phase I Trial of Allogeneic iNKT Cell Therapy (agenT-797) in Patients Undergoing Allogeneic Hematological Stem Cell Transplantation (SCT)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number Of Participants With Treatment-related Adverse Events
研究概览
简要总结
The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are:
- Is agenT-797 safe to use?
- What medical problems do participants have when taking agenT-797?
Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
详细描述
This study is being done to assess the safety and determine the maximum tolerated dose (MTD) of allogeneic invariant natural killer T (iNKT) cell therapy (agenT-797) in patients undergoing allogeneic hematological SCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 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
- •Age ≥18 years at the time of consent
- •Adult patients anticipated to get an allogeneic hematopoietic cell transplantation (allo-SCT)
- •All donor types are accepted (MMUD [mismatched unrelated donor], MUD [matched unrelated donor], MSD [matched sibling donor], haploidentical)
- •All conditioning regimens will be accepted (MAC [myeloablative conditioning], RIC [reduced-intensity conditioning], NMAC [non-myeloablative conditioning])
- •Karnofsky Performance Scale (KPS) > 70
- •Eligible Diagnoses:
- •Acute myeloid leukemia (AML) with intermediate/high-risk features or relapsed disease
- •Chronic myeloid leukemia (CML) in accelerated or blast phases
- •Myelodysplastic syndrome (MDS) with intermediate/high-risk features
- •Acute lymphoblastic leukemia (ALL) with high-risk features or relapsed disease
- •or any patients undergoing allogeneic stem cell transplant (allo-SCT) as standard of care could be eligible
排除标准
- •Excluded Diagnoses: Primary Myelofibrosis in the dose escalation phase and could be included in the dose-expansion phase
研究组 & 干预措施
Allogeneic iNKT Cells
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks.
干预措施: agenT-797 (Drug)
结局指标
主要结局
Number Of Participants With Treatment-related Adverse Events
时间窗: Baseline through Day 29 post cell infusion
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Number Of Dose-limiting Toxicities
时间窗: Baseline through Day 29 post cell infusion
次要结局
- Incidence of grade II-IV acute graft-versus-host disease (aGVHD)(Baseline through Day 29 post cell infusion)
- Incidence of severe grade III-IV aGVHD(Baseline through Day 29 post cell infusion)
- Progression-free Survival (PFS)(12 months)
- Non-relapse Mortalilty (NRM)(12 months)
- Relapse-free Survival (RFS)(12 months)
- Overall survival (OS)(12 months)
- Immune reconstitution based on lymphocyte subset panel(12 months)
- Immunoglobulin levels(12 months)
- Incidence of treatment-emergent adverse event (TEAE) infection(Baseline to 29 days post cell infusion)
- Type of infection(Baseline to 29 days post cell infusion)
- Donor Chimerism(Baseline to 29 days post cell infusion)
- Absolute neutrophil count (ANC)(Baseline to 29 days post cell infusion)
- Non-relapse mortality rate (NRM)(100 days)
- Relapse rate(100 days)
- GVHD incidence(100 days)