Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer

Launched by GRIT BIOTECHNOLOGY · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for patients with advanced lung cancer. The goal is to see if this treatment is safe and how well it works in helping patients whose cancer has not responded to other treatments. They are looking for patients aged 18 to 70 who have specific types of advanced lung cancer, including non-small cell lung cancer that has not responded to first-line therapy or small cell lung cancer with treatment failure. Participants should be in good health overall, with a life expectancy of at least 12 weeks, and should have measurable cancer lesions that can be tracked during the study.

If you decide to join the study, you will receive the GT201 injection, and the researchers will monitor your health closely to check for any side effects and to see how well the treatment is working. It’s important to note that participants cannot have severe pain that isn’t managed, and certain health conditions or recent drug treatments may prevent someone from being eligible. This trial is currently recruiting, so if you're interested or know someone who might be, it could be a valuable opportunity to explore a new potential treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 1.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;
• • 2.Known mental illness, alcoholism, drug use or substance abuse;
• • 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
• • 4.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;
• • 5.The investigators determine that other conditions that make the patient not suitable for enrollment.