Treatment of advanced gynecological tumors using GT201

Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors

This study is testing whether injections of modified immune cells can help people with advanced gynecological tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (industry)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, prednisone
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06834542 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the use of GT201, an autologous tumor infiltrating lymphocyte injection, in patients with advanced gynecological tumors. 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 receive injections of their own immune cells that have been modified to target their tumors. The study aims to gather preliminary data on how well this approach works in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced gynecological tumors who have at least one resectable lesion and an ECOG performance status of 0 or 1.

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 therapeutic option for patients with advanced gynecological tumors.

How similar studies have performed: While this approach is innovative, similar studies using tumor infiltrating lymphocytes have shown promise in other cancer types, suggesting potential for success.

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)

Where this trial is running

Shanghai, Shanghai

• Shanghai Jiaotong University School of Medcine, Renji Hospital Ethica Committee — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Wen Di

Conditions: Adult Gynecological Tumors