Using GTE-001 injection to treat 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
This study is testing a new injection called GTE-001 to see if it can safely help people with advanced lung adenocarcinoma feel better and improve their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06491225 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of GTE-001 injection, which utilizes autologous tumor-infiltrating lymphocytes, in patients with advanced lung adenocarcinoma. It is an open-label, multi-center Phase 1 trial that aims to assess the production feasibility of this treatment and identify potential biomarkers associated with its activity. Participants will be monitored for their response to the treatment and overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced lung adenocarcinoma that has progressed after initial chemotherapy.
Not a fit: Patients who have received prior engineered cell therapy or certain other treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung adenocarcinoma who have limited treatment choices.
How similar studies have performed: While this approach is innovative, similar studies using tumor-infiltrating lymphocytes have shown promise in other cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Beijing, Beijing
- Beijing GoBroad Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shasha Wang
- Email: 390150823@qq.com
- Phone: 86 （021）13641268212
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.