Treatment of advanced cervical cancer using GT201
Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)
This study is testing a new treatment called GT201, which uses immune cells to see if it can help people with advanced cervical cancer feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Drugs / interventions | radiation, cyclophosphamide, fludarabine, prednisone |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06191900 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the use of GT201, an autologous tumor infiltrating lymphocyte injection, for patients with advanced gynecological tumors, specifically advanced cervical cancer. The study is structured in two stages: a dose escalation stage followed by a dose extension stage, focusing on the safety and efficacy of the treatment. Participants will have at least one resectable lesion that has not been previously treated with radiation or local therapies. The study aims to explore the potential of this innovative immunotherapy approach in managing advanced cervical cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with advanced cervical cancer who have at least one resectable lesion and meet the eligibility criteria.
Not a fit: Patients with active autoimmune diseases or those requiring systemic steroid hormones may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new immunotherapy option for patients with advanced cervical cancer.
How similar studies have performed: While this approach is innovative, similar studies using tumor infiltrating lymphocytes have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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);
Where this trial is running
Shanghai, Shanghai
- Shanghai Tenth People's Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Zhongping Cheng, PHD
- Email: mdcheng18@263.com
- Phone: 13816686812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.