CARMIGO

  • Research type

    Research Study

  • Full title

    Chimeric Antigen Receptor (CAR)-T cells to target GD2 for Diffuse Midline Glioma (DMG)

  • IRAS ID

    1006322

  • Contact name

    Karin Straathof

  • Contact email

    k.straathof@ucl.ac.uk

  • Sponsor organisation

    University College London

  • Eudract number

    2022-002541-18

  • Clinicaltrials.gov Identifier

    NCT05544526

  • Research summary

    Around 10% of childhood brain tumours are Diffuse Midline Gliomas (DMG). These carry the worst prognosis: most children do not survive more than two years after diagnosis. DMGs grow in delicate parts of the brain which makes surgery usually impossible. Radiotherapy can temporarily stop tumour growth but the tumour will inevitably grow again.

    Chimeric antigen receptor (CAR) T-cells are immune cells which are genetically engineered so they can recognize and kill tumour cells. Sustained complete remissions have been achieved with CAR T-cells in leukaemia and encouraging results in non-blood cancers are emerging.

    We have developed CAR T-cells that recognize GD2 on neuroblastoma and DMG cancers. Our clinical study for children with neuroblastoma showed that GD2 CAR T-cells can find cancer cells in the body and start clearing them up. This study will test the GD2 CAR T-cells in patients with DMG and determine a safe dose and optimal way of giving these cells.

    What the study involves: T-cells are collected from the patient’s blood to make the GD2 CAR T-cells. Patients will have an Ommaya Reservoir placed under the skin of their scalp to monitor the pressure in the brain. Over 4 days they receive two chemotherapy drugs which help the CAR T-cells grow once inside the patient. The CAR T-cells are then given via a drip into the vein. The patient’s disease will be assessed 1 month later. If the tumour is still present and the CAR T-cells did not cause severe side effects, they may have a second CAR T-cell dose now given via the Ommaya reservoir into the fluid around the brain.

    If the GD2 CAR T-cells can be safely used in DMG and first signs of activity against the tumour are seen, this will inform further development of CAR T-cells for DMG and other brain tumours.

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    22/LO/0760

  • Date of REC Opinion

    18 Apr 2023

  • REC opinion

    Further Information Favourable Opinion