Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients

Study acronym: NESTLES
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Minor Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Dec 2025 to Aug 2025
    v38
  2. Minor Study completion date: Dec 2024 to Dec 2025v37
  3. Minor Study completion date: Dec 2023 to Dec 2024v36
  4. Minor Study completion date: Jun 2023 to Dec 2023v35
  5. Re-verified, no change to tracked fieldsv34
Show 32 earlier versionsHide 32 earlier versions
  1. Minor Study completion date: Dec 2021 to Jun 2023v33
  2. 4 versions Re-verified since Feb 28, 2019, no change to tracked fieldsv29-v32
  3. Notable Primary endpoint revised
    • Interventions: 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)
    v28
  4. 7 versions Re-verified since Apr 29, 2013, no change to tracked fieldsv21-v27
  5. Minor Enrollment target: estimated 18 to confirmed 19v20
  6. Minor Primary completion date changed from estimate of Dec 2021 to Jan 2010
    • Study description shortened, about 983 words
    v19
  7. Re-verified, no change to tracked fieldsv18
  8. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v17
  9. 2 versions Re-verified since Mar 4, 2011, no change to tracked fieldsv15-v16
  10. Minor Eligibility criteria revised
    • Study description revised
    • Site details revised
    v14
  11. 3 versions Re-verified since Jun 12, 2010, no change to tracked fieldsv11-v13
  12. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v10
  13. Re-verified, no change to tracked fieldsv9
  14. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  15. Notable Primary endpoint revisedv7 Show 5 more changesShow less
    • Interventions: 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) (Biological), 14g2a.zeta transduced… to 14g2a.zeta chimeric receptor transduced autologous EBV specific cytotoxic T-lymphocytes (EBV-CTL) w/o lymphodepletion (Biological)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 1,231 words
    • Study arms: 0 to 1
  16. Minor Site contact updatedv6
  17. Notable Primary endpoint revised
    • 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…
    • Secondary endpoints expanded, about 35 words
    v5
  18. Minor Collaborators expanded, about 10 wordsv4
  19. Study Status, Outcome Measuresv3
  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Trial Details
NCT Number NCT00085930
Lead Sponsor Baylor College of Medicine
Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions
(from sponsor)
Neuroblastoma
Related terms Neuroblastoma
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov