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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
GD2 CAR T cells
Biological/VaccineInfusion with: GD2 CAR T-cells
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: GD2 CAR T CellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the ATIMP
Toxicity of GD2 CAR T cells as assessed by the incidence of grade 3-5 toxicity causally related to the ATIMP (particularly severe cytokine release syndrome and severe neurotoxicity).
Time frame
28 days2
Feasibility of manufacturing GD2 CAR T-cells evaluated by the number of therapeutic products generated
Feasibility of generation of the ATIMP as evaluated by the number of therapeutic products generated and the number of ATIMPs infused (as an intravenous agent (Theme 1) and as an intraventricular agent (Theme 2) after successful manufacture.
Time frame
28 daysSecondary outcomes
1
Overall survival (OS)
The proportion of patients alive at 1 year will be tabulated. If numbers are sufficient, overall survival will also be analysed using Kaplan-Meier survival analyses. Survival times will be measured from the date of GD2 CAR T infusion until the date of death from any cause.
Time frame
1 year2
Progression Free Survival (PFS)
The proportion of patients alive and progression-free at 1 year will be tabulated. Progression-free survival will be analysed using Kaplan-Meier survival analyses with the median survival time reported. Survival times will be measured from the date of the GD2 CAR T infusion until the date of progression or death.
Time frame
1 year3
Time to Progression (TTP)
TTP will be summarised as a median and range. If numbers are sufficient, this will also be analysed using Kaplan-Meier survival analyses with the duration calculated as the time from first response (≥PR) until progression
Time frame
1 year4
Best objective response rate (ORR)
This will be taken as the best response as defined by RAPNO criteria observed at any time point following CAR T infusion. The number and proportion of patients achieving a response ≥PR will be presented for all patients as well as by dose level.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov