Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients with Advanced Lung Adenocarcinoma

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

PHASE1

Total Enrollment

12 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 Multiple centers, open design aimed at evaluating the safety,efficacy and Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection ) for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential biomarkers related to GTE-001 activity.

Related Clinical Trials

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

Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors

NCT06094426

Solid Tumor Adult GT316

RECRUITING EARLY_PHASE1

Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours

NCT06397963

Solid Tumor, Adult

RECRUITING NA

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-lymphoma

NCT06633341

T-lymphoblastic Lymphoma

RECRUITING EARLY_PHASE1

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

NCT05430373

Solid Tumors, Adult

RECRUITING PHASE1

Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors

NCT05117138

Melanoma Non-small Cell Lung Cancer Head and Neck Squamous Cell Carcinoma

UNKNOWN PHASE1/PHASE2

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.

Advanced Lung Adenocarcinoma；Adult

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.

GTE001 injection treatment group

Group Type EXPERIMENTAL

GTE001 injection

Intervention Type BIOLOGICAL

GTE-001 injection to treat Advanced lung adenocarcinoma

Interventions

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

GTE001 injection

GTE-001 injection to treat Advanced lung adenocarcinoma

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 years old;
* 3\. Advanced lung adenocarcinoma that progresses after recurrence or first-line chemotherapy；
* 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5\. Expected survival time of ≥ 3 months;
* 6\. Good function of vital organs;
* 7\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria

* 1.Subject has previously received an allogeneic stem cell transplant or organ allograft,Subject has previously received engineered cell therapy,Prior FOLR1 directed therapy is not allowed unless it had been with an approved agent in the indication;
* 2.Subject has undergone surgery or received radiotherapy, immunotherapy, targeted therapy agents, anticancer vaccines, systemic steroids, or chemotherapy within 2 weeks of enrolment. Targeted agents, such as tyrosine kinase inhibitors, may be continued until 5 half-lives before enrolment;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
* 4.History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No