GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
GT101: Autologous tumor infiltrating lymphocyte injection
Study summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.
The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes:
1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).
2. GT101 infusion.
3. post-infusion treatment (interleukin-2 intravenous push).
Eligibility
Primary outcome measure(s)
- Safety Profile Measured by Grade ≥3 TEAEs — 3 years
To characterize the safety profile of autologous TIL injection(GT101) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs) - Objective response rate — 3 years
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator - Overall survival — 3 years
To evaluate efficacy parameters such Overall Survival (OS) - Progression-free survival — 3 years
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator - Disease Control Rate — 3 years
To evaluate efficacy parameters such disease control rate (DCR) per RECIST 1.1, as assessed by investigater - Duration of Response — 3 years
To evaluate efficacy parameters such duration of response (DoR) per RECIST 1.1, as assessed by investigater
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| The fifth medical center of the General Hospital of the Chinese people's Liberation Army | Beijing | Beijing Municipality | Recruiting |
| Chongqing University Cancer Center | Chongqing | Chongqing Municipality | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | Sichuan | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05430373 on ClinicalTrials.gov ↗ ← All trials in China