A Study of GC203 TIL in Advanced Solid Tumors (NF)

A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Solid Tumors

This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.

Inclusion Criteria:

• have one the tumor resection for gene-edited GC203 TIL production and successfully produced；
• Age: 18 years to 75years;
• Histologically diagnosed as solid tumor;
• Expected life-span more than 3 months;
• ECOG score 0-1;
• Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 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