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

Phase 1

Recruiting

• Conditions: Advanced Lung Adenocarcinoma；Adult
• Interventions: Biological: GTE001 injection

• Registration Number: NCT06491225
• Lead Sponsor: Grit Biotechnology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-06-30
• Study First Posted: 2024-07-09
• Study Start: 2024-07-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-07-18
• Study Completion: 2027-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GTE001 injection treatment group	GTE001 injection	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China