Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours

Launched by GRIT BIOTECHNOLOGY · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Autologous Tumor-Infiltrating Lymphocyte (GT307) for patients with solid tumors, specifically looking at its safety and how well it works. The trial is currently recruiting participants who are between 18 and 70 years old and have ovarian cancer that has continued to grow despite previous treatments. To join, patients should be in relatively good health and have a certain level of physical ability, which is measured using a simple scoring system. Importantly, participants need to have at least one measurable tumor that can be tracked during the study.

If you join the trial, you'll receive the GT307 treatment and be monitored closely to see how your body responds. The researchers want to learn more about the right dosage and how the treatment affects your cancer. It's essential to know that there are specific criteria that could prevent some people from participating, such as uncontrolled pain, recent drug trials, or certain health conditions. Overall, this study aims to explore a promising treatment option while ensuring participants’ safety and well-being.

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. Ovarian cancer 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 ≥ 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.