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

A Phase I, Open Label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients With Advanced Lung Adenocarcinoma

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06491225

Enrollment

Registered

2024-07-09

Start date

2024-07-18

Completion date

2024-08-27

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Lung Adenocarcinoma；Adult

Brief summary

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.

Interventions

BIOLOGICALGTE001 injection

GTE-001 injection to treat Advanced lung adenocarcinoma

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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;

Design outcomes

Primary

Measure	Time frame	Description
Objective response rate	3 years	To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026