Tumor Infiltrating Lymphocyte (TIL) Therapy for the Treatment of Advanced Solid Tumors
Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients. TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.
Objective: To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.
Eligibility: Adults aging 18-75 with advanced solid tumor.
Design: 1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. 2. Freshly resected patient tumors were dissected by the surgeon. 3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded. 4. At last TIL cells will be re-infused into the patients.
• Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
• Age ≥ 18 years and ≤ 75 years.
• Expected survival time \> 3 months.
• ECOG score 0-1.
• At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for TIL preparation.
• At least 1 measurable lesion (according to RECIST v1.1).
• Metastatic or recurrent solid tumor, confirmed by histopathology. Patients who have failed previous standard treatment or currently do not have standard treatment, or who have been determined by the researcher to be unsuitable for current standard treatment due to other reasons.
• Any previous anti-tumor treatment must exceed 28 days when collecting tumor tissue; The tumor tissue used for collecting and preparing TIL should not have undergone local treatment.
• The bone marrow function of the subject's meets the following requirements:
∙ Absolute neutrophil count (ANC) ≥ 1.5× 10e9/L.
‣ Platelet (PLT） ≥ 75× 10e9/L.
‣ Hemoglobin (HGB) ≥ 90 g/L.
⁃ Liver and kidney function:
• Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min.
∙ Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of ULN.
∙ Total bilirubin (TBIL) ≤ 1.5 times of ULN.
⁃ Blood coagulation function:
• Prothrombin time (PT) ≤ 1.5 ULN.
∙ International Normalized Ratio (INR) ≤ 1.5 ULN.
∙ or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
⁃ Left Ventricular Ejection Fractions (LVEF）≥45%.
⁃ Forced Expiratory Volume in the first second (FEV1）≥50%.
⁃ Women or men of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug.