C7R-GD2.CART cells (IV and ICV infusion)

Dose levels administered are by IV infusion followed by ICV infusion. Cycle 1: 20 million cells/m2 delivered IV with lymphodepletion. Cycle 2 (and subsequent cycles): Dose level 1: 5 million cells ICV with lymphodepletion.

To prepare the brain cancer specific GD2-C7R T cells, research staff will take some blood from the patient. The researchers will grow the GD2.C7R T cells by infecting the T cells with a retroviral vector (a special virus that can carry a new gene into cells) containing one gene that can recognize and kill brain cancer cells GD2.CAR and the new gene called C7R that will help these cells survive longer.

After the new genes have been put into the T cells, the cells will be tested to make sure that they kill GD2-positive brain cancer cells. All patients on this study are required to have an Ommaya catheter in place prior to treatment as a precaution and for infusion of the T cells. This is a special catheter that leads to the tumor, the cavity left in the brain after surgical removal of the tumor, or into the fluid-filled space in the brain.

In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses GD2. Cohort 2 is for patients with a type of cancer called progressive diffuse intrinsic pontine glioma that expresses GD2.

Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients.

Live record on ClinicalTrials.gov →

• Procurement Inclusion Criteria:
• Histologically confirmed, GD2-expressing newly diagnosed DMG/HGG (including pontine) or confirmation of H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available. Newly diagnosed is defined as prior to radiographic progression or recurrence.
• Histologically confirmed, GD2-expressing recurrent, refractory, or progressive DMG/HGG (except pontine) or confirmation of positive H3K27 alteration if sufficient tissue for GD2 staining by IHC is not available.
• Recurrent, refractory, or progressive high-grade CNS tumor with confirmed GD2-expression. Examples include: medulloblastoma "CNS embryonal tumors, AT/RT, ependymal tumors, diffuse gliomas or glioneuronal tumors.
• Recurrent, refractory, or progressive pontine HGG with confirmed GD2-expression or H3K27-altered DMG
• Tumors less than 5 cm in maximum dimension at enrollment

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.