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Pediatric Neuroblastoma - Healing Genes
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Pediatric Neuroblastoma

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GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Children With Neuroblastoma (GINAKIT2)

GD2 Specific Chimeric Antigen Receptor (CAR) and Interleukin-15 Expressing Autologous Natural Killer T-cells to Treat Children With Neuroblastoma


Phase 1

DESCRIPTION:

Researchers at Texas Children’s Hospital seek children with neuroblastoma to trial an investigatory treatment that gene-modifies their own immune natural killer T cells (NKT) to add 3 genes:

  • A gene to produce molecules on their surface that recognize neuroblastoma cells
  • A gene to make the NKT cells live longer
  • A gene to produce Interleukin 15 (IL-15) which stimulates immune response to tumors

After leukapheresis to collect the T-cells, they are gene-modified in the lab, then returned to the patient following chemotherapy. Follow up may continue for up to 15 years.


PATIENT MUST:

  • Be 1 to 21 years of age
  • Have relapsed or refractory high risk neuroblastoma
  • Life expectancy of at least 12 weeks
  • Weigh greater than 12kg

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Leukapheresis to isolate T-cells which are then modified in the lab.
  3. Chemotherapy for 3 days.
  4. The gene-modified T cells will be administered through an IV line following a day of rest.
  5. Follow up will be required for 15 years.

LOCATIONS & CONTACTS:
The study site is at Texas Children’s Hospital in Houston, TX Map.

Contacts:
Andras Heczey, MD    |  832-824-4233  |  [email protected]
Josalind Randall  |  832-824-6835  |  [email protected]
 
SPONSORS
Baylor College of Medicine
Center for Cell and Gene Therapy, Baylor College of Medicine
Texas Children’s Hospital
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03294954

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