A Phase I Study of GC101 TIL in Advanced Solid Tumors

Inclusion criteria

• ✓. Patients must be ≥18 and ≤75 years of age at the time of consent.
• ✓. Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
• ✓. At least one measurable target lesion even after resection, as defined by RECIST1.1.
• ✓. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• ✓. Patients must have an estimated life expectancy of ≥3 months.
• ✓. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
• ✓. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
• ✓. Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy.