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โ† Trials
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NKG2D.Zeta-NK Cell Conditioning With C7R.GD2.CAR-T Cells for Patients With Relapsed or Refractory Osteosarcoma or Neuroblastoma

RecruitingPhase 1Ages 1 Year - 24 YearsAllBaylor College of Medicine
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to find the largest safe dose of i15.NKG2D.zeta-NK cells in combination with C7R.GD2.CAR-T cells, and additionally to evaluate how long they can be detected in patients' blood and what affect they have on patients' cancer. Patients eligible for this study have neuroblastoma or osteosarcoma that expresses a substance on the cancer cells called GD2. This cancer has either come back after treatment or did not respond to the standard or other investigational treatments or therapies used to treat it. There is no standard treatment for these types of advanced cancers at this time. This is a gene transfer research study using special immune cells called NK cells and T cells. NK cells and T cells are types of white blood cell that help the body fight infection. The body has different ways of fighting infection and disease. No single way seems perfect for fighting c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
PROCUREMENT INCLUSION: 1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease. 2. Karnofsky/Lansky score of 60% or greater. 3. Informed consent and assent (as applicable) obtained from parent/guardian and child. 4. Greater than 1 year of age. PROCUREMENT EXCLUSION: 1. History of hypersensitivity to murine protein-containing products. 2. Known presence of Human Anti-Mouse Antibodies (HAMA). 3. Active autoimmune disease (requiring immunosuppressive treatment in the past 6 months). 4. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required). TREATMENT INCLUSION: 1. Patients with Neuroblastoma that have persistent disease after standard treatment or have relapsed/refractory disease. Or Patients with Osteosarcoma that have persistent disease after standard treatment or have relapsed/refractory disease. 2. Karnofsky/Lansky score of 50% or greater 3. Pulse Ox greater than or equal to 90% on room air 4. AST less than 5 times upper limit of normal (less than 10 times upper normal if known with metastatic liver disease) 5. Total bilirubin less than 3 times the upper limit of normal 6. Serum creatinine less than 3 times upper limit of normal 7. Available autologous T-cells with greater than or equal to 20% expressing GD2.CAR 8. Informed consent and assent (as applicable) obtained from parent/guardian and child. 9. Greater than 1 year of age. 10. Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study. TREATMENT EXCLUSION: 1. History of hypersensitivity to murine protein containing products (patients who have undergone desensitization and successful re-challenge without hypersensitivity reaction are eligible). 2. Known presence of Human Anti-Mouse Antibodies (HAMA). 3. Tumor potentially causing airway obstruction per investigator discretion. 4. Pregnancy or lactation / will not use birth control methods. 5. Currently receiving immunosuppressive drugs (patients on low dose corticosteroids are eligible: less than 0.25 mg/kg/day of prednisone/equivalent). 6. Primary brain tumor or known brain metastases (on evaluation by MIBG and/or PET if applicable, CT/MRI/LP not required).
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What it tests

  • i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
  • i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
  • i15.NKG2D.zeta NK cells and C7R.GD2.CARTs cells
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Where

1 site
Texas Children's Hospital
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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