RecruitingNot ApplicableNCT06519669
Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer
A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients with Advanced Lung Cancer
Sponsor
Grit Biotechnology
Enrollment
40 participants
Start Date
Jul 18, 2024
Study Type
INTERVENTIONAL
Conditions
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 cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria8
- \. Voluntarily join the study, signed informed consent form，willing and able to comply with the study protocol;
- \. Age 18 to 70 years old;
- \. 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;
- \. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- \. Expected survival time of ≥ 12 weeks;
- \. Good function of vital organs;
- \. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
- \. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
Exclusion Criteria5
- 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.
Interventions
BIOLOGICALGT201 injection
GT201 injection to treat Advanced lung cancer
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06519669
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