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Diffuse Intrinsic Pontine Glioma - Healing Genes
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Diffuse Intrinsic Pontine Glioma

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Phase I Study of Autologous T Lymphocytes Expressing GD2-specific Chimeric Antigen and Constitutively Active IL-7 Receptors for the Treatment of Patients With GD2-expressing Brain Tumors (GAIL-B)

C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)


Phase 1

DESCRIPTION:

Researchers in Texas Children’s Hospital are seeking for patients with high grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).This research study combines two different ways of fighting cancer: antibodies and T cells.Many of these cancers have GD2 protein on their surface.They will make a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2 and put this gene into the patients’ own T cells.They will added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.They also will grow the GD2.C7R T cells by infecting the T cells with a retroviral vector containing one gene that can recognize and kill DIPG/HGG cells (GD2.CAR) and the new gene called C7R that will help these cells survive longer. The cells generated will be frozen and stored to give back to the patient.Cyclophosphamide and fludarabine will be given intravenously for 2 days and then fludarabine alone on the third daybefore infusion of T cells.Patients will be followed for a total of 15 years.The GD2.C7R T cells are an investigational product not approved by the Food and Drug Administration.


PATIENT MUST:

  • Be 12 Months to 18 Years old
  • Have measurable disease on at least 2 dimensions on MRI
  • Have completed radiation therapy at least 4 weeks prior to administration of investigational agent
  • Have adequate organ function as defined in the protocol
  • Not be pregnant or breast feeding

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate
  2. Researches will make a CAR gene and put it into the patients’ own T cells
  3. They will added the gene C7R
  4. The cells generated will be frozen and stored
  5. Cyclophosphamide and fludarabine will be given intravenously
  6. Infusion of T cells
  7. Patients will be followed for a total of 15 years

LOCATIONS AND CONTACTS:
Trials will take place at:
Texas Children’s Hospital, United States
Contact:
Bilal Omer, MD, 832-824-4665, [email protected]

SPONSOR INFORMATION:
Baylor College of Medicine
Texas Children’s Hospital
Center for Cell and Gene Therapy, Baylor College of Medicine

Or go online:
https://clinicaltrials.gov/ct2/show/NCT04099797

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