Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors

Launched by GRIT BIOTECHNOLOGY · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called GT201 for adults with advanced gynecological tumors. The study is designed to explore the safety and effectiveness of this treatment in two stages: first, it will gradually increase the dose given to participants to find the best amount, and then it will extend the treatment to more patients at that dose. The trial is currently recruiting participants, and anyone aged between 18 and 75 years who has a suitable tumor that can be surgically removed may be eligible to join.

To participate, patients should be in good overall health (with a fitness score of 0 or 1, meaning they can carry out daily activities without much difficulty) and must be able to understand the study and provide written consent. However, certain individuals, such as those with active autoimmune diseases or recent serious blood clotting issues, cannot participate. Those who join the trial can expect to receive the study treatment and be monitored closely for safety and effectiveness. This study is an opportunity for patients to receive a new treatment option that could help in their fight against cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
• • 2. The physical fitness status score of the ECOG is 0 or 1
• • 3. At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;
• Exclusion Criteria:
• • 1. The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
• • 2. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
• • 3. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
• • 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
• • 5. Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)