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项与 Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI) 相关的临床试验Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 F5 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization
Background:
Melanoma antigen recognized by T-cells (MART)-1 is a protein present in melanoma cells.
An experimental procedure developed for treating patients with melanoma uses the anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5 cells that are designed to destroy the patient's tumor. These cells are created in the laboratory using the patient's own tumor cells or blood cells.
The treatment procedure also uses a vaccine called plaque purified canarypox vector (ALVAC) MART-1, made from a virus that ordinarily infects canaries and is modified to carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells.
Objectives:
-To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating patients with advanced melanoma.
Eligibility:
-Patients 18 years of age with metastatic melanoma for whom standard treatments have not been effective.
Design:
Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment.
Patients have 7 days of chemotherapy to prepare the immune system for receiving the anti-MART-1 F5.
Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses.
After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.
Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 F5 TCR-Gene Engineered Lymphocytes
Background:
Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type,HLA-A 0201 (human leukocyte antigen) derived from the gp100 protein. A retroviral vector was constructed that can deliver the T-cell receptor (TCR) to cells.
Patients' cells will be converted into cells able to recognize and fight melanoma tumors.
Objectives:
To determine whether TCR-engineered lymphocytes can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors.
To evaluate safety and effectiveness of the treatment.
Eligibility:
Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site).
Patient's leukocyte antigen type is HLA-A 0201.
Design:
-Patients undergo the following procedures:
Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-MART-1 protein is inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment.
Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment.
Treatment with anti-melanoma antigen recognized by T-cells (MART)-1. Patients receive an intravenous (IV) infusion of the treated cells containing anti-MART-1 protein, followed by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of the treated white cells.
Patients are given support medications to prevent complications such as infections.
Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue).
Patients are evaluated with laboratory tests and imaging tests, such as CT (computed tomography) scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months to determine the response to treatment.
Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.
100 项与 Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI) 相关的临床结果
100 项与 Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI) 相关的转化医学
100 项与 Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI) 相关的专利（医药）
100 项与 Autologous anti-MART-1 F5 T-cell receptor gene-engineered tumor infiltrating lymphocytes(NCI) 相关的药物交易
