GT201 Injection For The Treatment Of Advanced Solid Tumors

Inclusion Criteria:

• 1. The Patients (or legally authorized representative) Patients (or legally authorizedrepresentative) must have the ability to understand the requirements of the study,have provided written informed consent as evidenced by signature on an informedconsent form (ICF) approved by an Institutional Review Board/Independent EthicsCommittee (IRB/IEC), must have the ability to understand the requirements of thestudy;
• 2.Must have a confirmed diagnosis of malignancy of their receptive histologies orcytologies;
• 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) thathas not been treated with radiation and has not received other local therapies. Theseparated tissues ≥1.0cm^3 (either of single lesion origin or multiple lesionscombined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimallyinvasive treatment where possible.

Exclusion Criteria:

• 1.The patient who has any active autoimmune disease, history of autoimmune disease,need for systemic steroid hormones or a condition requiring immunosuppressive drugtherapy (>10 mg/day of prednisone or equivalent hormone);
• 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as:cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• 3. Patients who have refractory or intractable epilepsy, poorly controlledhydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;
• 4. Participate in other clinical trials within 4 weeks prior to the first dose of thisstudy, or planning to participate in this study and other clinical trials at the same;
• 5. Patients who have received allogeneic bone marrow transplantation or an organallograft;
• 6.Patients who have a history of hypersensitivity to any component or excipient ofstudy drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine,IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin).