NCT07830342尚未招募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
- 尚未招募
- 入组人数
- 12
- 主要终点
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as part of safety and tolerability assessment
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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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, regardless of sex;
- •Histologically and/or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (defined as more than 50% clear cell component); previously failed at least one line of standard therapy;
- •At least one tumor lesion suitable for collection that has not received radiotherapy or other local treatment within 28 days prior to screening, and meets the collection requirements;
- •At least one measurable tumor lesion as defined by RECIST 1.1 after tumor tissue sampling;
- •ECOG performance status of 0 or 1;
- •Life expectancy of at least 3 months;
- •Adequate organ function as assessed by laboratory tests and other examinations during the screening period;
- •Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor tissue collection, with the exception of toxicities judged by the investigator to pose no safety risk (such as hyperthyroidism, alopecia);
- •Agree to use effective non-pharmacologic contraceptive measures from the time of signing the informed consent form until the end of the study;
- •Fully understand the trial, 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
- •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; intranasal or topical corticosteroid use is permitted.
- •Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study (except debulking surgery performed for tumor tissue collection).
- •Systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection.
- •Receipt of a live vaccine within 3 months prior to screening or planned administration of a live vaccine during the study.
- •History of severe hypersensitivity reactions to any drug used during the study.
- •Prior treatment with a similar cell therapy product.
- •Prior organ transplantation or hematopoietic stem cell transplantation.
- •Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation.
- •Any of the following 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.
- •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.
- •Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage.
- •Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment.
- •Severe respiratory disease.
- •Known leptomeningeal metastasis; symptomatic central nervous system metastases, unless previously treated and clinically stable (MRI) for at least 12 weeks.
- •Any uncontrolled clinical problem.
- •Active autoimmune disease requiring systemic treatment during the study.
- •Presence of acute or chronic infection:
- •Pregnant or breastfeeding women.
- •Known psychiatric disorder, alcohol abuse, drug abuse, or substance abuse.
- •Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment 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
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
未报告次要终点
研究者
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