Chimeric Antigen Receptor (CAR)-T Cells to Target GD2 for Diffuse Midline Glioma
The CARMIGO Trial is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and young adults aged 2-16 years with Diffuse Midline Glioma (DMG). The study will evaluate the feasibility of generating the ATIMP, the safety and tolerability of the GD2CAR T-cell therapy and how effectively GD2CAR T-cells engraft, expand and persist following administration in patients with DMG.
• Age ≥ 2 and ≤ 16 years
• Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.
• Radiographically evident tumour restricted to the brain stem or spinal cord.
• At least 6 weeks following completion of radiation therapy.
• At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial
• Performance status: Karnofsky (age ≥ 10 years) or Lansky (age \< 10) score ≥ 40% allowing for stable neurological deficit due to DMG
• Absolute neutrophil count ≥1.5 x109/L and platelet count ≥ 100 x109/L
• Total bilirubin \< 1.5 ULN and ALT \< 2.5 ULN
• Serum creatine \< 1.5 ULN for age.
⁃ For post-pubertal subjects agreement to have a pregnancy test, use adequate contraception (if applicable)
⁃ Written informed consent