GT201

Yongsheng Wang, PHD

Haifeng Qing

Xiaorong Dong, PHD

Yuping Sun, PHD

Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified "3+3" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional "3+3" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional "3+3" dose-escalation principle,The second and third dose groups are based on the traditional "3+3" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.

GT201 Injection For The Treatment Of Advanced Solid Tumors

A Single-Arm Phase I/II Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors

Safety Profile Measured By Grade ≥ 3 TREAs for CTCAE 5.0

Tumor imaging determines the changes in tumor size at baseline and after treatment.Tumor imaging evaluation according to RECIST v1.1

Grit Biotechnology

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

GT201 injection in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer

GT201 injection in combination with teraplizumab injection

Yayi He, PHD

Jin Li, PHD

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) in combination with teraplizumab injection for treatment of patients with non-small cell lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer

Safety Profile Measured by Grade ≥3 TRAEs by CTCAE 5.0

Zhengxiang Han, PhD

Xingya Li, PhD

Kai Chen, PhD

Youguo Chen

This study is a multi-center, single-arm phase I clinical trial. A total of 26\~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

A Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

To characterize the safety profile of autologous TIL injection（GT201) 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)

Symptoms and General Pathology

Recurrence

Weijia Fang, PhD

This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors

Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GT201 Injection For The Treatment Of Advanced Solid Tumors	NCT06144671	Solid Tumor, Ad...	GT201	18 Years - 70 Years	Grit Biotechnology
GT201 Injection For The Treatment Of Advanced Solid Tumors	NCT06144671	Solid Tumor, Ad...	GT201	18 Years - 70 Years	Grit Biotechnology
GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer	NCT06235242	Adult Non-small Cell ...	GT201 injection...	18 Years - 70 Years	Grit Biotechnology
Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors	NCT05729399	Solid Tumor	GT201	18 Years - 70 Years	Grit Biotechnology
GT201 Injection in Combination With Teraplizumab Injection for Treatment of Patients With Non-small Cell Lung Cancer	NCT06235242	Adult Non-small Cell ...	GT201 injection...	18 Years - 70 Years	Grit Biotechnology
Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors	NCT05430360	Solid Tumor	GT201	18 Years - 70 Years	Grit Biotechnology

Spots Global Cancer Trial Database for gt201

Every month we try and update this database with for gt201 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 gt201

Every month we try and update this database with for gt201 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 gt201 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.