Status:
RECRUITING
Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients with Advanced Lung Adenocarcinoma
Lead Sponsor:
Grit Biotechnology
Conditions:
Advanced Lung Adenocarcinoma；Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
- 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;
- 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;
- Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
- History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06491225
Start Date
July 18 2024
End Date
July 18 2027
Last Update
February 21 2025
Active Locations (1)
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1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200