A Study of TIL in Advanced Solid Tumors (DFGD)

A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Inclusion Criteria:

• have one the tumor resection for TILs production and successfully produced；
• Age: 18 years to 75years;
• Histologically diagnosed as solid tumors;
• Expected life-span more than 3 months;
• ECOG score 0-1;
• Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;
• At least 1 evaluable tumor lesion;

Exclusion Criteria:

• with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
• Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;
• Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is < 95%;
• Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
• Significant cardiovascular anomalies