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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2027-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05729399

Solid Tumor

RECRUITING PHASE1/PHASE2

GT201 Injection For The Treatment Of Advanced Solid Tumors

NCT06144671

Solid Tumor, Adult

RECRUITING PHASE1/PHASE2

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

NCT05430360

Solid Tumor

RECRUITING PHASE1

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

NCT06235242

Adult Non-small Cell Lung Cancer

RECRUITING NA

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

NCT06077903

Adult

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adult Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GT201 treatment group

Group Type EXPERIMENTAL

GT201 injection

Intervention Type BIOLOGICAL

GT201 injection to treat Advanced lung cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GT201 injection

GT201 injection to treat Advanced lung cancer

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No