Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Advanced Colorectal Cancer

Launched by GRIT BIOTECHNOLOGY · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Autologous Tumor-Infiltrating Lymphocyte (GT307) for patients with advanced colorectal cancer, which is cancer that has spread and continued to grow even after initial chemotherapy. The main goal of the study is to evaluate how safe this treatment is and how well it works, while also determining the best dose to use. The trial is currently recruiting participants aged 18 to 70 who have experienced cancer progression after their first round of chemotherapy and have good overall health.

To participate, individuals need to be willing to join the study and follow the guidelines, have a specific type of advanced colorectal cancer, and have a life expectancy of at least 12 weeks. It's important that potential participants do not have severe pain from their tumors that cannot be controlled, and they should not be pregnant or breastfeeding. Those who join the study can expect close monitoring of their health and the effects of the treatment throughout the trial. This research could help provide new options for people facing advanced colorectal cancer.

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. Advanced Colorectal Cancer that progresses after first-line chemotherapy；
• • 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