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

NCT06491225 | Terminated Phase 1

• 1 other identifier: GTE-001-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Lung Adenocarcinoma；Adult

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  3 years

Study Arms (1)

GTE001 injection treatment group

EXPERIMENTAL

Biological: GTE001 injection

Interventions

GTE001 injection BIOLOGICAL

GTE-001 injection to treat Advanced lung adenocarcinoma

GTE001 injection treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
• \. Age ≥18 years old;
• \. Advanced lung adenocarcinoma that progresses after recurrence or first-line chemotherapy；
• \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• \. Expected survival time of ≥ 3 months;
• \. Good function of vital organs;
• \. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

You may not qualify if:

• 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;
• 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;
• Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
• History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 9, 2024
• Study Start: July 18, 2024
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)