Autologous Tumor Infiltrating Lymphocyte Injection for the Treatment of Advanced Solid Tumors

Launched by GRIT BIOTECHNOLOGY · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment method called Autologous Tumor Infiltrating Lymphocyte Injection for patients with advanced solid tumors, which are types of cancer that form solid masses, like in the breast or lungs. The main goal of the trial is to see how safe this treatment is and how well it works for patients. It is taking place at multiple locations and is currently looking for participants who are between the ages of 18 and 75 and have specific types of cancer that cannot be easily removed by surgery. To participate, individuals need to have a confirmed diagnosis and at least one tumor that can be safely collected for the treatment preparation.

Participants in the trial will receive the treatment and will be monitored closely for any side effects or changes in their condition. It’s important to note that not everyone can join the trial; for instance, people with certain medical conditions, like active autoimmune diseases or recent serious blood clot events, may be excluded. If you or a loved one is interested in learning more about this trial, it could be a potential opportunity to access an innovative treatment while contributing to important research in cancer therapy.

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.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.Patients with ≥3 untreated CNS metastases at the time of screening (patients were included if they had ≤3 CNS metastases with a maximum diameter of \<1 cm and no peritumor edema on brain imaging (MRI or CT) and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment)
• • 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 with refractory or intractable epilepsy, drug-uncontrolled pleural effusion, abdominal effusion, pericardial effusion, active gastrointestinal bleeding or contraindications to IL-2;
• • 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);