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Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer

A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients with Advanced Lung Cancer

NCT06519669•Grit Biotechnology

View on ClinicalTrials.gov

Summary

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Voluntarily join the study, signed informed consent form，willing and able to comply with the study protocol;
•2\. Age 18 to 70 years old;
•3\. Queue 1: Late stage non-small cell lung cancer without driver genes that have failed first-line systemic treatment;Queue 2: Small cell lung cancer with first-line systemic treatment failure;
•4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
•5\. Expected survival time of ≥ 12 weeks;
•6\. Good function of vital organs;
•7\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
•8\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria

•1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
•2.Known mental illness, alcoholism, drug use or substance abuse;
•3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
•4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
•5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Locations (2)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 18, 2024

Primary Completion Date

July 18, 2027

Completion Date

July 18, 2027

Last Updated

February 17, 2025

Enrollment

ESTIMATED participants

Conditions

AdultLung Cancer

Interventions

GT201 injection

BIOLOGICAL

Contacts

Hongmin Lu, PHD

CONTACT

+86 （021）13671774876 renjilhm@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer

Inclusion Criteria

Exclusion Criteria

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