This is a multicenter Phase I/II clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.
1. Voluntarily enroll in the study, sign the informed consent form (ICF), and be willing and able to comply with the study protocol.
2. Aged 18 to 70 years old. For subjects older than 70 years old, eligibility shall be jointly determined by the Investigator and the Sponsor's Medical Monitor.
Phase I trial: Patients with advanced solid tumors who have failed standard therapy, have no available standard therapy, or cannot tolerate standard therapy.
Phase II trial: Patients with the target indication who have progressed or are intolerant after receiving the specified treatment outlined in the protocol, and who meet the inclusion and
4. At least one lesion that is resectable for the preparation of autologous TIL cells.
5. At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Estimated survival time ≥ 12 weeks.
Single group
GT201
Biological/VaccineInfusion
IL-2
Biological/VaccineInjection
PD-1 inhibitor
Biological/VaccineInjection
Adverse events (AEs)
Incidence and severity of AEs, SAEs and AE leading to treatment interruption and discontinuation will be graded per NCICTCAE v5.0 (Phase 1)
Changes in laboratory parameters
Evaluate the safety and tolerability based on changes in laboratory parameters before and after treatment. (Phase 1)
Objective Response Rate (ORR)
Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 2).
Objective Response Rate (ORR)
Proportion of participants achieving a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 (Phase 1).
Disease control rate (DCR)
Proportion of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST 1.1 (Phase 1 and Phase 2).
Progression free survival (PFS)
The time from GT201 infusion to the first documentation of progressive disease (PD) per RECIST 1.1 or death from any cause, whichever occurs first (Phase 1 and Phase 2).
Duration of Response (DOR)
The duration from the first confirmed objective response per RECIST 1.1 to the first documentation of progressive disease (PD) or death from any cause (Phase 1 and Phase 2).
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