Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated from a business perspective.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lung Adenocarcinoma;Adult | Lung Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GTE001 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GTE001 injection treatment group
- interventionNames
- Biological: GTE001 injection
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available