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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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing GoBroad Hospital
RECRUITING
Beijing
Contact Information
Primary
Shasha Wang
390150823@qq.com
86 (021)13641268212
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2027-07-18
Participants
Target number of participants: 12
Treatments
Experimental: GTE001 injection treatment group
Related Therapeutic Areas
Sponsors
Leads: Grit Biotechnology

This content was sourced from clinicaltrials.gov

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