Injection of immune cells to treat advanced gynecological tumors

Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT316) in the Treatment of Advanced Solid Tumors (gynecological Tumors)

This study is testing if injecting immune cells can help people with advanced gynecological cancers feel better and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Grit Biotechnology (Industry-sponsored)
• Drugs / interventions: radiation, cyclophosphamide, fludarabine, prednisone, chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06145802 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of autologous tumor-infiltrating lymphocyte injection (GT316) in patients with advanced solid tumors, specifically gynecological cancers. The study is structured in two phases: a dose-escalation phase followed by an expansion phase. Participants will undergo a screening period, a sampling and production period for the immune cells, a chemotherapy period, and a treatment and observation period, culminating in a follow-up phase to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable recurrent or metastatic solid tumors who have at least one resectable lesion for immune cell preparation.

Not a fit: Patients with tumors that are resectable or have received prior local therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel immunotherapy option for patients with advanced gynecological tumors.

How similar studies have performed: Other studies using similar immunotherapy approaches have shown promise, indicating potential for success in this trial.

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.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
* 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 ≥1.0cm\^3 (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. Subjects with ≥3 untreated CNS metastases at screening (If the subject has ≤3 CNS metastases with a maximum diameter of \<1cm, and there is no peritumor edema on brain imaging (MRI or CT).no evidence of progressive CNS disease on brain imaging at least 3 months after treatment, then subjects will be included.);
* 2.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);
* 3. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring
* 4. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis,pericardial effusion, active gastrointestinal bleeding or IL-2 contraindications;
* 5. Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same
* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 7.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

Conditions Solid Tumor; Gynecological Tumors