NCT07830342招募中1 期
A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
研究概览
简要总结
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 18 to 75 years;
- Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;
- At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and/or biopsied for the preparation of autologous tumor-infiltrating lymphocytes;
- After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
- ECOG performance status ≤ 1;
- Adequate organ and bone marrow function as assessed during the screening period;
- Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography; no arrhythmia requiring treatment; Fridericia-corrected QT interval (QTcF) ≤ 470 ms; baseline oxygen saturation > 91% on room air;
- Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor sampling;
- Agree to use effective non-pharmacological contraceptive measures from the time of signing informed consent until 1 year after TIL cell infusion;
- Fully understand the trial and voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.
排除标准
- Patients with a history of severe hypersensitivity reactions to any drug used during the study;
- Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
- Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
- Active autoimmune disease requiring systemic treatment during the study;
- History of organ transplantation or hematopoietic stem cell transplantation;
- Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease that, in the investigator's judgment, requires immunosuppressive medication during the study. However, physiological doses of glucocorticoids, intranasal or topical corticosteroids are allowed;
- Received systemic anticancer therapy within 4 weeks prior to preconditioning, or plan to participate in another interventional clinical trial during the study;
- Presence of acute or chronic infection, including: HIV positive, positive Treponema pallidum antibody, or clinically active hepatitis B or C; Active infection requiring systemic treatment or active tuberculosis infection;
- Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study;
- Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of lymphodepleting preconditioning, adoptive TIL therapy, and IL-2 adjuvant therapy;
- Diagnosis of another primary malignancy within 5 years prior to screening, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ;
- Severe respiratory disease;
- Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation;
- Known leptomeningeal metastasis; known other central nervous system metastases that are not effectively controlled after treatment or untreated;
- Previous treatment with a similar cell therapy product;
- Pregnant or breastfeeding women;
- Known psychiatric disorders, alcoholism, drug abuse, or substance abuse, and any other condition that the investigator considers unsuitable for participation in this study.
研究组 & 干预措施
HS-IT101 monotherapy
Experimental
TIL Injection administered by intravenous infusion over 30-60 minutes
干预措施: Interleukin 2 subcutaneous injection (Drug)
HS-IT101 monotherapy
Experimental
TIL Injection administered by intravenous infusion over 30-60 minutes
干预措施: Fludarabine (Drug)
HS-IT101 monotherapy
Experimental
TIL Injection administered by intravenous infusion over 30-60 minutes
干预措施: Cyclophosphamid (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
时间窗: 2 years
Evaluate the preliminary efficacy of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
时间窗: 2 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as part of safety and tolerability assessment
时间窗: 1 year
次要结局
- Evaluate the pharmacokinetic (PK) characteristics of HS-IT101 injection.(2 years)
研究者
研究点 (1)
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标识符
- NCT 编号
- NCT07830342
- 其他研究编号
- HS-IT101-105
日期
- 首次提交
- (15天前)
- 首次发布
- (9天前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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