C7R-GD2.CAR T Cells for GD2-expressing Brain Tumors

This study is testing a special type of cell therapy called C7R-GD2.CART cells for patients aged 12 months to 25 years with certain types of GD2-expressing brain tumors, including Diffuse Intrinsic Pontine Glioma and High Grade Glioma. GD2 is a protein found on some cancer cells. The C7R-GD2.CART cells are your own immune T cells that have been specially modified in the lab to recognize and fight these cancer cells. You would receive these cells through an IV (into a vein) and ICV (into the fluid-filled space in the brain) infusion. The main goal of this study is to see how safe this treatment is and to identify any dose-limiting toxicities (side effects that are severe enough to stop treatment). The study aims to enroll 56 participants.

Study design
This is an interventional study with two treatment groups (cohorts) for different types of GD2-expressing brain tumors. It is not specified if it is randomized or blinded.
What's involved
You would have blood drawn to create the C7R-GD2.CART cells and undergo lymphodepletion (a treatment to reduce certain immune cells) before receiving the infusions. An Ommaya catheter (a special tube) would be placed in your brain for the ICV infusions.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, dose limiting toxicity, is measured at 4 weeks after the T cell infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04099797

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

Recruiting
PHASE1Ages 12–25InterventionalTreatment
Baylor College of Medicine
~56 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:C7R-GD2.CART cells (IV and ICV infusion)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT) rate
Measured over 4 weeks post T cell infusion
Diffuse Intrinsic Pontine Glioma
High Grade Glioma
Embryonal Tumor
Ependymal Tumor
1 sites across 1 states
Texas1
  • Jasia Mahdi, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • Bilal Omer, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

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  • Dose limiting toxicity (DLT) rate4 weeks post T cell infusion

    DLT rate is defined as the proportion of subjects with DLT evaluated as per the NCI CTCAE v5.0 with the exception of CRS and neurological toxicities that are related to T cell infusions.