Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors (SOLID-NK)
A Phase 1/2, Open-Label, Dose-Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of EB-NK-301 (Allogeneic TROP2-Targeted CAR NK Cells) Following Lymphodepleting Chemotherapy in Adults With Advanced or Metastatic TROP2-Expressing Solid Tumors
study evaluates EB-NK-301, an investigational off-the-shelf allogeneic CAR-NK cell product targeting TROP2, in adults with advanced or metastatic solid tumors that express TROP2 and have progressed after standard therapy.
The primary goals are to assess safety and tolerability, identify dose-limiting toxicities (DLTs), and determine a recommended Phase 2 dose (RP2D). Secondary goals include preliminary anti-tumor activity, persistence of infused CAR-NK cells, and exploratory immune biomarkers.
研究概览
详细说明
Study Overview: The study includes two parts. Part A (dose escalation) uses a standard dose-escalation design to evaluate multiple dose levels of EB-NK-301 after lymphodepleting chemotherapy. Part B (dose expansion) enrolls additional participants at the selected RP2D to further characterize safety and to estimate preliminary efficacy within selected tumor-type cohorts.
Treatment Plan: Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by intravenous EB-NK-301 infusions. Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.
Assessments: Tumor imaging is performed every 8 weeks during the first 12 months, then every 12 weeks as clinically indicated. Blood samples are collected to assess CAR-NK cell persistence, cytokines, and other immune biomarkers.
Follow-up: Participants are followed for safety and survival for up to 24 months after first infusion.
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：shan S Lu, Phd
- 电话号码：+86 13076790030
- 邮箱：Seni-Lu@beijing-biotech.com
学习地点
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Guangdong
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Shenzhen、Guangdong、中国、518036
- 招聘中
- Peking University Shenzhen Hospital
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接触：
- Zhen J Peng, Phd
- 邮箱：Zhen-Peng@beijing-biotech.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18 to 75 years at the time of informed consent.
- Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation).
- Disease progression on, intolerance to, or ineligibility for available standard therapy.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status 0 to 1.
- Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits.
- Life expectancy ≥ 12 weeks.
- Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential).
- Ability to understand and willingness to sign written informed consent.
Exclusion Criteria:
- Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks).
- Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection.
- Active autoimmune disease requiring systemic immunosuppression.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia).
- Receipt of another investigational agent within 2 weeks (or 5 half-lives, whichever is longer) prior to lymphodepleting chemotherapy.
- Prior gene-modified cellular therapy within 3 months prior to enrollment.
- Systemic corticosteroid therapy > 10 mg/day prednisone equivalent within 7 days prior to lymphodepletion (excluding physiologic replacement).
- Pregnant or breastfeeding.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Dose Escalation
Sequential dose escalation of EB-NK-301 following lymphodepleting chemotherapy to evaluate safety, DLTs, and identify RP2D.
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Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.
其他名称：
Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.
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实验性的：Dose Expansion
Expansion cohorts at the RP2D in selected TROP2-expressing tumor types to further assess safety and preliminary efficacy.
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Investigational allogeneic CAR-NK cell product targeting TROP2, administered by intravenous infusion.
其他名称：
Lymphodepleting chemotherapy administered prior to EB-NK-301 infusion to facilitate immune cell engraftment and persistence.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of dose-limiting toxicities (DLTs) (CTCAE v5.0)
大体时间：28 days
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28 days
|
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Incidence and severity of treatment-emergent adverse events (AEs)
大体时间：12 months
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12 months
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Recommended Phase 2 dose (RP2D) of EB-NK-301
大体时间：6 months
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6 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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总生存期（OS）
大体时间：24个月
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24个月
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缓解持续时间 (DoR)
大体时间：24个月
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24个月
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Objective response rate (ORR) per RECIST 1.1
大体时间：12 months
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12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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