Phase I Study of GD2 CAR T-Cell Therapy for Children and Young Adults Aged 2 to 16 with Diffuse Midline Glioma

What this Trial Is About

The CARMIGO Trial is a Phase I clinical study conducted at a single center, focusing on children and young adults aged 2 to 16 years with Diffuse Midline Glioma DMG, a type of brain tumor. The trial aims to evaluate an Advanced Therapy Investigational Medicinal Product ATIMP called GD2CAR T-cell therapy. Researchers will study the safety, tolerability, and how well these engineered T-cells engraft, expand, and persist in patients with DMG. Participants will have their own T-cells collected through unstimulated leukapheresis, which takes about 15 days to produce the GD2CAR T-cell product. Before infusion, patients will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide and have an Ommaya catheter placed to monitor and manage increased intracranial pressure. The therapy is given intravenously at one of three dose levels. Patients who do not fully respond or whose disease progresses may receive a second dose of CD19CAR T-cells via the Ommaya reservoir after similar chemotherapy. Following the GD2CAR T-cell infusion, patients stay in the hospital for 2 to 4 weeks for close monitoring. After discharge, follow-up visits occur at 6 weeks and then every 3 months for one year. If relapse occurs within that year, patients exit the interventional follow-up and are followed annually until trial completion. All patients then enter long-term follow-up until the study ends, during which safety, treatment feasibility, survival outcomes, and tumor responses are assessed.

CAR T Cells to Target GD2 for DMG