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Autologous tumor infiltrating lymphocyte injection

GT101

Haifeng Qin, PhD

Yongsheng Wang, PhD

Donglin Zou, PhD

Yongsheng Li, PhD

Jian Zhang, PhD

Dongmei Ji, PhD

Xiubao Ren, PhD

This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, clear lung pretreatment 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).

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

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)

To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

To evaluate efficacy parameters such Overall Survival (OS)

Grit Biotechnology

Yi Zhang, PHD

This study is a single center, single arm phase I clinical trial. This study proposes to enroll 20 subjects, with a trial protocol including chemotherapy pretreatment, reinfusion of autologous tumor infiltrating lymphocyte injection, and interleukin-2 injection.

GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

A Single Center, Single Arm Phase I Clinical Study of GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

The incidence of grade ≥3 TEAEs as Assessed by CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors	NCT05430373	Solid Tumors, A...	GT101	18 Years - 70 Years	Grit Biotechnology
GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors	NCT06077903	Adult	GT101	3 Years - 70 Years	Grit Biotechnology
GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors	NCT06077903	Adult	GT101	3 Years - 70 Years	Grit Biotechnology

Spots Global Cancer Trial Database for gt101

Every month we try and update this database with for gt101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gt101

Every month we try and update this database with for gt101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gt101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.