A Phase I/II Open-Label Clinical Study of Autologous Tumor Infiltrating Lymphocyte Infusion (GT201) in the Treatment of Advanced Solid Tumors
This is a multicenter, single-arm phase 1/2 clinical trial to evaluate the safety and tolerability of GT201 as a monotherapy or in combination with anti-PD-1 therapy in patients with advanced solid tumors, and to evaluate the efficacy of this therapy.
Inclusion Criteria: Key eligibility criteria for inclusion in the study: * 1 Age 18\~70 years old; * 2 Diagnosed with: Phase 1 part: Patients with advanced solid tumors who have failed all standard therapy, have no standard therapy, or are intolerant of standard therapy Phase 2a part: Patients with an advanced or metastatic solid tumor enrolled in one of three (3) indications selected for dose expansion based on Phase 1 safety and preliminary activity. Patients must have progressed on or after standard-of-care therapy, or for whom no suitable standard therapy is available; * 3 At least one lesion that is resectable for the preparation of autologous TIL cells; * 4 At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling; * 5 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; * 6 Expected survival ≥ 12 weeks; * 7 Non-surgically sterilized women of reproductive age who agree to use at least one medically recognized method of contraception during the study treatment period and for 1 year after the end of the study treatment period; and must have a negative serum test at screening, prior NMA-LD and cell infusion.
Exclusion Criteria: Subjects will be excluded from the study for one or more of the following conditions: * 1 Patients with spinal cord compression that has failed to resolve after surgery and/or radiotherapy (patients with clinical evidence that symptoms have resolved after surgery or radiation therapy for ≥ 1 week prior to surgical sampling are eligible for enrollment); * 2 Bleeding events within 3 months prior to screening * 3 Patients with arterio-venous thrombotic events that occurred within 3 months prior to screening * 4 Have interstitial pneumonia or active pneumonia that is clinically significant at screening, or other respiratory conditions that severely affect lung function; * 5 Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association (NYHA) Class grade \> grade 2; * 6 Participants with ≥ 3 untreated central nervous system (CNS) metastases; * 7 Have any historical or active autoimmune disease requiring systemic steroids, or immunosuppressive therapy (\> 10 mg/day of prednisone or equivalent); * 8 Malignant tumors other than the target indication within 5 years; * 9 The presence of refractory or intractable epilepsy, large amounts of pleural effusion, ascites, pericardial effusion, etc. that cannot be controlled by drugs, or other contraindications to IL-2 use; * 10 Patients with infectious diseases, will be excluded from the study; with some exceptions for HBV and HCV. * 11 Previous allogeneic bone marrow transplantation or solid organ transplantation;
[{"measure":"To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors","timeFrame":"Upto 2 years"},{"measure":"To assess the safety of GT201 in the treatment of recurrent or metastatic solid tumors","timeFrame":"Upto 2 years"},{"measure":"To assess the tolerance of GT201 and decide on the recommended Phase 2 dose.","timeFrame":"Upto 2 years"},{"measure":"To assess the Objective Response Rate (ORR) of GT201 infusion in accordance with RECIST v1.1","timeFrame":"Upto 2 years"}]