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MinorTrial status: Active, Not Recruiting to CompletedStudy completion date changed from estimate of Dec 2025 to Aug 2025v38Show 1 more changeShow less
Study completion date changed from estimate of Dec 2025 to Aug 2025
MinorCompletion date: Dec 2024 to Dec 2025v37
MinorCompletion date: Dec 2023 to Dec 2024v36
MinorCompletion date: Jun 2023 to Dec 2023v35
MinorRe-verified, no change to tracked fieldsv34
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MinorCompletion date: Dec 2021 to Jun 2023v33
Minor4 versionsRe-verified since Feb 28, 2019, no change to tracked fieldsv29-v32
NotablePrimary endpoint revisedInterventions: 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) w/o lymphodepletion (Biological) to EBV specific CTLs (Biological) · Secondary endpoints revised (3)v28Show 2 more changesShow less
Interventions: 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) w/o lymphodepletion (Biological) to EBV specific CTLs (Biological)
NotablePrimary endpoint revisedPrimary and study completion dates: Dec 2021 · Interventions: 14g2a (Genetic), CTLs (Genetic) to 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) (Biological), 14g2a.zeta transduced… · Secondary endpoints expanded, about 35 wordsv5Show 3 more changesShow less
Primary and study completion dates: Dec 2021
Interventions: 14g2a (Genetic), CTLs (Genetic) to 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) (Biological), 14g2a.zeta transduced…
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients have high-risk neuroblastoma, a form of cancer typically found in children. The patients previously participated in a gene transfer research study using special immune cells. This research study combines two different ways of fighting disease, antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other infections. T cells, also called cytotoxic T lymphocytes or CTLs, are special infection-fighting blood cells that can kill some tumor cells. Both antibodies and T cells have been used to treat patients with cancers and while they have shown promise, they have not been strong enough to cure most patients. The antibody used in this study is called 14g2a. This antibody sticks to neuroblastoma cells because of a substance on the outside of these cells called GD2. 14g2a and other antibodies that bind to GD2 have been used to treat people with neuroblastoma. For this study 14g2a has been changed so that instead of floating free in the blood, it is now joined to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. T lymphocytes or CTLs can kill tumor cells but there normally are not enough of them to kill all tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the patient. Sometimes an antibody or chimeric receptor is attached to these T cells to help them bind to tumor cells. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. We have found that T cells that are also trained to recognize the virus that causes infectious mononucleosis, Epstein Barr Virus (EBV), can stay in the blood stream for many years. By joining the 14g2a antibody to the CTLs that recognize EBV, we believe we will make a cell that can last a long time in the body (because they are EBV-specific) and recognize and kill neuroblastoma cells (because an antibody that can recognize these cells has been placed on their surface). Patients received treatment with the immune cells described above. They may want to receive an additional dose of these cells. This is being offered as an option because their neuroblastoma has returned and they have enough cells remaining to provide the patients with an additional dose. These 14g2a antibody CTLs are an investigational product not approved by the Food and Drug Administration.