Overview
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.
Eligibility
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
