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

Grit Biotechnology

Status and phase

Enrolling

Phase 1

Conditions

Advanced Lung Adenocarcinoma；Adult

Treatments

Biological: GTE001 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06491225

GTE-001-001

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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