Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)

Launched by GRIT BIOTECHNOLOGY · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GT201 for patients with advanced gynecological tumors, specifically advanced cervical cancer. The study is divided into two parts: the first part looks at increasing doses of the treatment to find the best amount to use, while the second part will focus on using that dose for more patients. The trial is currently recruiting participants, and people aged between 18 and 75 years are eligible to join, as long as they have a confirmed diagnosis of an advanced solid tumor and at least one lesion that can be treated.

To participate, patients need to understand the study and give their consent by signing a form. They should not have certain health issues, like untreated brain tumors or recent serious blood clots. If someone joins the trial, they will receive the new treatment and be monitored closely to see how it works and if it helps their condition. This is an important opportunity for patients who may not have other treatment options available.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The Patients (or legally authorized representative) 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.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 3 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);