Overview

An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.

Eligibility

Inclusion Criteria:

1. Age: 18 to 75 years old;
2. Patients with advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) who have been confirmed by cytology or histology and have failed at least one line of standard first-line therapy. Patients with non-squamous NSCLC who are negative for EGFR/ALK/ROS1 driver mutations.
3. There must be at least one tumor lesion that has not undergone radiation therapy or other local treatments within the past 28 days, which will be used to prepare autologous tumor-infiltrating lymphocytes, and it must meet the tissue sampling requirements.
4. After sampling, there must be at least one measurable lesion that meets the RECIST 1.1 criteria definition, and this lesion has not undergone radiotherapy or other local treatments;
5. ECOG score ≤ 1;
6. The expected survival time is ≥ 3 months;
7. During the screening period, the assessments showed adequate organ and bone marrow function,
8. Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%; no arrhythmias requiring treatment; QT interval corrected by the Fridericia method (QTcF) ≤470 ms; baseline blood oxygen saturation \>91% in ambient air conditions;
9. Prior to tumor sampling, adverse reactions induced by previous treatments have recovered to Grade 1 (5.0) or below according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
10. From the signing of the informed consent form to one year after TIL cell infusion, agree to adopt effective non-pharmacological contraception measures;
11. Those who fully understand this trial and voluntarily sign the informed consent form, and are able to comply with the visits and related procedures stipulated in the protocol.

Exclusion Criteria:

1. Patients who have previously experienced severe allergic reactions to drugs used during the research process;
2. Presence of any uncontrolled clinical conditions, including but not limited to: poorly controlled hypertension; congestive heart failure;
3. Within the past 6 months, the following conditions have occurred: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
4. Autoimmune diseases that are active and require systemic treatment during the study period;
5. Organ transplantation or a history of hematopoietic stem cell transplantation;
6. Within 4 weeks prior to tumor tissue sampling, the subject has used any immunosuppressive drugs, such as steroid medications, or the investigator determines that there are comorbid conditions requiring the use of immunosuppressive drugs during the trial. However, physiological doses of glucocorticoids are permitted, and intranasal or local use of steroid medications is allowed;
7. Individuals who have received systemic anti-tumor treatment within the 4 weeks prior to pre-treatment or those planning to participate in other interventional clinical trials during the study period;
8. Presence of acute or chronic infections, active infections requiring systemic treatment, or active tuberculosis infection;
9. Individuals who have undergone major organ surgery or suffered significant trauma within the past 4 weeks, or who require elective surgery during the trial period;
10. Patients with pre-selection surgical complications or delayed healing, and those judged by the researcher to be at increased risk for lymph node clearance pretreatment, adoptive TIL therapy, and IL-2 adjuvant therapy;
11. Within the 5 years prior to screening, diagnosed with concurrent other primary malignant tumors, excluding completely resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or in situ carcinoma that has undergone radical excision;
12. Suffering from severe respiratory diseases;
13. Patients with gastrointestinal bleeding requiring surgical treatment, or those with localized intestinal ischemia or perforation;
14. Patients with known leptomeningeal metastasis; patients with other central nervous system metastases that are not effectively controlled by treatment or have not been treated;
15. Has previously received similar cell therapy products;
16. Pregnant or lactating women;
17. Individuals with known mental illnesses, alcoholism, drug or substance abuse, or those deemed unsuitable by other researchers to participate in this trial.