GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

Launched by GRIT BIOTECHNOLOGY · Oct 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with advanced solid tumors that cannot be surgically removed, known as metastatic or recurrent tumors. The trial will include 20 participants who will first receive chemotherapy to prepare their bodies, followed by an injection of their own immune cells, called tumor-infiltrating lymphocytes, which are meant to help fight the cancer. Additionally, participants will receive a medication called interleukin-2 to boost the immune response.

To be eligible for the study, participants must have a confirmed diagnosis of an advanced solid tumor and at least one area of cancer that can be treated. They should also be able to understand the study and provide written consent. However, those with certain conditions, like active infections or autoimmune diseases, may not be able to participate. If someone joins the trial, they can expect to receive these treatments at a single medical center and be closely monitored throughout the study. It’s important to understand that this is an early-phase trial, meaning the treatment is still being tested for safety and effectiveness.

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 mass Volume ≥1cm\^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 who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
• • 2.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;
• • 3. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
• • 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);