Frontlight ResearchEarly access
TerminatedPhase 1
Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients With Advanced Lung Adenocarcinoma
Key facts
- Who runs it
- Grit Biotechnology
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 2 people enrolled
- Started
- 18 Jul 2024
- Ended
- 27 Aug 2024
- Type of study
- Interventional
- Treatments tested
- GTE001 injection
- Record updated
- 23 April 2026
- Why it stopped
- The study was terminated from a business perspective.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 4.History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency
- 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- GTE001 injection treatment groupTreatment being tested
Treatment: GTE001 injection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 23 April 2026