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NAI for Sepsis With Persistent Lymphopenia

2026年5月5日 更新者：ImmunityBio, Inc.

Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia

This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count <1,000 cells/µL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and potentially Day 21 if ALC remains <1,000 cells/µL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Sepsis is characterized by a biphasic immune response: an initial hyperinflammatory phase followed by a prolonged immunosuppressive phase with persistent lymphopenia. The majority of sepsis deaths (>70%) occur during the immunosuppressive phase rather than the initial hyperinflammatory phase. This acquired immunosuppression correlates with markedly increased 28-day mortality rates exceeding 40% and significantly elevated risk of secondary infections.

This study evaluates NAI, an IL-15 receptor agonist that promotes proliferation and activation of NK cells and CD8+ T cells, as a potential therapy to restore immune function in critically ill adults with sepsis and persistent lymphopenia (ALC <1,000 cells/µL on two consecutive measurements within 72 hours of sepsis diagnosis).

Study Arms:

  • Experimental Arm: NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier than Day 3 if ALC is <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
  • Control Arm: Institutional standard of care for sepsis alone Standard of care may include antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated. Treatment will be discontinued if a participant has unacceptable toxicity, withdraws consent, or if the Investigator feels it is no longer in the participant's best interest to continue.

All participants will be followed for 90 days post the first dose of study treatment to capture late adverse events, rehospitalization, or mortality.

研究类型

介入性

注册 (估计的)

50

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age 18 years or older at the time of informed consent
  2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points
  3. Documented persistent lymphopenia defined as ALC <1,000 cells/µL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)
  4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines
  5. Ability to obtain written informed consent from the participant or legally authorized representative
  6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)

Exclusion Criteria:

  1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes
  2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening
  3. Active cytokine release syndrome (CRS) at screening
  4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)
  5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening
  6. High-dose immunosuppressive therapy (>0.5 mg/kg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock
  7. Life expectancy less than 24 hours as assessed by the treating physician
  8. Active uncontrolled bleeding requiring >2 units of packed red blood cells in the preceding 24 hours
  9. Known HIV infection with CD4 count <350 cells/µL and detectable viral load
  10. Known active viral hepatitis (hepatitis B or C with detectable viral load)
  11. Advanced dementia or other conditions precluding meaningful participation
  12. Known hypersensitivity to any component of the investigational products
  13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening
  14. Pregnant or breastfeeding

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：NAI + Standard of Care
NAI 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL, plus institutional standard of care for sepsis
药品：Nogapendekin alfa inbakicept (NAI)
IL-15 receptor agonist complex; 1.2 mg subcutaneous injection administered on Days 3 (or earlier if ALC <700 cells/µL), Day 14, and Day 21 if needed for ALC <1,000 cells/µL
其他名称：
  • N-803
  • 安克提瓦
  • Nogapendekin alfa-inbakicept
其他：Standard of Care (SOC)
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated
有源比较器：Standard of Care Alone
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, and mechanical ventilation as clinically indicated
其他：Standard of Care (SOC)
Institutional standard of care for sepsis including antimicrobial therapy, fluid resuscitation, vasopressor support, organ support, and mechanical ventilation as clinically indicated

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
28-day all-cause mortality rate
大体时间：28 days
Proportion of participants who die from any cause within 28 days of randomization
28 days

次要结果测量

结果测量
措施说明
大体时间
Change in absolute lymphocyte count (ALC)
大体时间：Baseline through Day 28
Change in ALC from baseline (Day 1 pre-dose) through Day 28
Baseline through Day 28
ICU re-admission rate
大体时间：Up to Day 90
Proportion of participants re-admitted to ICU after discharge by Day 90
Up to Day 90
Secondary infections
大体时间：Up to Day 90
Proportion of participants with secondary infections after discharge by Day 90
Up to Day 90
90-day all-cause mortality rate
大体时间：90 days
Proportion of participants who die from any cause within 90 days of randomization
90 days
Safety and tolerability
大体时间：Through Day 30 after last dose
Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and Grade ≥3 TEAEs graded per NCI CTCAE v6.0
Through Day 30 after last dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ImmunityBio, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月6日

初级完成 (估计的)

2027年8月3日

研究完成 (估计的)

2027年10月4日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ResQ2204-SEPSIS

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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