TILs Therapy for Multiple Primary Early-Stage NSCLC

Официальное название

Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Обзор

This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC

Подробное описание

This study is an open-label, single-arm, prospective clinical trial. 50 subjects with multiple primary early-stage non-small cell lung cancer (NSCLC), including those with malignant pleural effusion, will be enrolled and administered with tumor-infiltrating lymphocytes (TILs) injection therapy. Adverse reactions, therapeutic efficacy and other relevant indicators will be closely observed and followed up, so as to systematically evaluate the safety and effectiveness of TILs treatment for multiple

Вмешательства

• Препарат TILs injection
  Experimental: Surgically collect fresh tumor tissue or malignant pleural effusion to isolate immune cells, and prepare TILs Infusion. Trial product: TILs Injection. Administration route: Intravenous Infusion

Первичные конечные точки

• According to the incidence of treatment-related adverse events（AEs）to evaluate the safety of Tumor-Infiltrating Lymphocytes (TILs) therapy for multiple primary early-stage Non-Small Cell Lung Cancer （NSCLC） [Срок оценки: up to three years]

Вторичные конечные точки (1)

• According to the subgroup analysis of TILs in patients with multiple primary early-stage NSCLC to analyze the correlation between TILs and disease prognosis [Срок оценки: up to three months]

Критерии участия

Критерии включения

• Age 18-75 years, male or female;
• Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation;
• Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments;
• Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;
• ECOG performance status score of 0-2;
• HGB ≥70 g/L, transfusion-eligible;
• No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria:

Creatinine ≤ 1.5 × ULN; Oxygen saturation > 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;

• Estimated survival > 5 years with complete clinical documentation.

Критерии исключения

• Patients with pathological diagnosis of small cell lung cancer components;
• Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;
• Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;
• Patients currently undergoing steroid therapy;
• Concurrent severe or persistent infections unresponsive to effective control;
• Concurrent severe autoimmune disease or congenital immunodeficiency;
• History of severe allergic reactions to biological products (including antibiotics);
• Active hepatitis (quantitative hepatitis B virus DNA \[HBV-DNA\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \[HCV-Ab\] with HCV-RNA above the assay method's lower limit of detection);
• HIV infection or syphilis infection;
• Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;
• Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07498439 · TILs NSCLC-SZ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗