CAR T Cells to Target GD2 for DMG
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 16
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Systemic corticosteroid therapy ≥ 0.05 mg/kg dexamethasone daily (or equivalent) at time of RQR8/huK28Z CAR T cell infusion
Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)
Clinical or radiological evidence of true tumour progression
Active hepatitis B, C or HIV infection
Trial design
Treatments tested in this trial
- GD2 CAR T cells
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov