Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma (SELECT-NK-THYM)
A Phase 1/2, Open-Label, Target-Selected Study of Allogeneic CAR-NK Cells Directed to CD30, CD5, or Mesothelin in Patients With Relapsed/Refractory B2 Thymoma or Thymic Carcinoma
研究概览
地位
条件
详细说明
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:Seni S Lu, Phd
- 电话号码:+86 13076790030
- 邮箱:Seni-Lu@beijing-biotech.com
学习地点
-
-
Guangdong
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Shenzhen、Guangdong、中国、518036
- 招聘中
- Peking University Shenzhen Hospital
-
接触:
- Zhen J Peng, Phd
- 电话号码:+86 13076790039
- 邮箱:Zhen-Peng@beijing-biotech.com
-
-
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 consent.
- Histologically confirmed B2 thymoma or thymic carcinoma that is unresectable, metastatic, or recurrent.
- Relapsed or refractory after at least 1 prior systemic therapy (including a platinum-based regimen for thymic carcinoma when appropriate) or no standard curative option available.
- Tumor antigen positivity for at least one of the following by central laboratory assessment: CD30, CD5, or mesothelin. Cohort assignment is based on the dominant target (pre-specified algorithm) and feasibility of manufacturing/availability.
- Measurable disease per RECIST v1.1 (or evaluable disease if measurable disease is not feasible; to be specified).
- ECOG performance status 0-1 (0-2 may be permitted in expansion at investigator discretion).
- Adequate organ function: ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 8 g/dL (transfusions allowed), AST/ALT ≤ 3 x ULN (≤ 5 x ULN with liver involvement), total bilirubin ≤ 1.5 x ULN (except Gilbert's), creatinine clearance ≥ 50 mL/min.
- Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception.
- Ability to understand and sign informed consent.
Exclusion Criteria:
- Active central nervous system involvement by malignancy requiring immediate therapy.
- Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 90 days or unresolved ≥Grade 2 toxicity from prior cellular therapy.
- Uncontrolled infection, including active tuberculosis, or uncontrolled hepatitis B or C infection; known uncontrolled HIV infection.
- Clinically significant autoimmune disease requiring systemic immunosuppression (e.g., >10 mg/day prednisone equivalent) within 14 days of conditioning, except for stable endocrine replacement.
- Prior allogeneic hematopoietic stem cell transplant with active graft-versus-host disease or ongoing immunosuppression.
- Significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction), uncontrolled arrhythmia, or QTc prolongation felt to increase risk.
- Pregnancy or breastfeeding.
- Concurrent participation in another interventional trial with an investigational anticancer agent within 21 days (washout required).
- Any condition that, in the investigator's judgment, would interfere with safe participation or interpretation of results.
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: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:Cohort A: CD30-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
淋巴细胞清除
淋巴细胞清除
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if clinically indicated
|
|
实验性的:Cohort B: CD5-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
淋巴细胞清除
淋巴细胞清除
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if clinically indicated
|
|
实验性的:Cohort C: Mesothelin-CAR-NK
Lymphodepleting chemotherapy: cyclophosphamide + fludarabine (Days -5 to -3), followed by CAR-NK infusion on Day 0. A second infusion on Day 7 may be permitted at investigator discretion in Phase 2 if no ≥Grade 3 treatment-related toxicity is observed and product is available. |
淋巴细胞清除
淋巴细胞清除
CD30-targeted allogeneic CAR-NK cells
CD5-targeted allogeneic CAR-NK cells
Mesothelin-targeted allogeneic CAR-NK cells
ctivate the iCasp9 safety switch if 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 |
|---|---|---|
|
Incidence of Dose-Limiting Toxicities (DLTs)
大体时间:28 Days
|
DLTs as defined in protocol, assessed during the DLT window after the first CAR-NK infusion.
Includes severe infusion-related toxicity, Grade >=3 organ toxicity attributable to CAR-NK cells, severe CRS or neurotoxicity, and treatment-related death.
|
28 Days
|
|
Recommended Phase 2 Dose
大体时间:28 Days
|
Determined separately for each cohort based on DLTs, overall safety, and pharmacodynamic data
|
28 Days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Response Rate
大体时间:12 months
|
Proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 (or modified criteria appropriate for thymic tumors) in each cohort.
|
12 months
|
|
Disease Control Rate
大体时间:12 months
|
Proportion of participants with CR, PR, or stable disease
|
12 months
|
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EB-CARNK-THYM-009
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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