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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