Status:
RECRUITING
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer
Lead Sponsor:
Grit Biotechnology
Conditions:
Adult
Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung canc...
Eligibility Criteria
Inclusion
- 1\. Voluntarily join the study, signed informed consent form，willing and able to comply with the study protocol;
- 2\. Age 18 to 70 years old;
- 3\. Queue 1: Late stage non-small cell lung cancer without driver genes that have failed first-line systemic treatment;Queue 2: Small cell lung cancer with first-line systemic treatment failure;
- 4\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- 5\. Expected survival time of ≥ 12 weeks;
- 6\. Good function of vital organs;
- 7\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
- 8\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
Exclusion
- Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
- Known mental illness, alcoholism, drug use or substance abuse;
- Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
- Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
- The investigators determine that other conditions that make the patient not suitable for enrollment.
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06519669
Start Date
July 18 2024
End Date
July 18 2027
Last Update
February 17 2025
Active Locations (2)
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1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
2
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127