Multi-modular Chimeric Antigen Receptor Targeting GD2 in Neuroblastoma
United Kingdom12 participantsStarted 2024-04-19
Plain-language summary
MAGNETO is a single-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in children and teenagers aged 1-16 years with relapsed or refractory neuroblastoma.
The study will assess the feasibility of generating the ATIMP (GD2 CAR T cells) and the safety of administering the ATIMP in patients with relapsed or refractory neuroblastoma.
Who can participate
Age range1 Year – 16 Years
SexALL
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Inclusion criteria
✓. Age ≥ 1 and ≤ 16 years.
✓. Tissue diagnosis of neuroblastoma. If sufficient biopsy material is available, GD2 expression on the tumour will be confirmed. As GD2 is consistently expressed in neuroblastoma demonstration of GD2 is not mandated.
✓. Disease which has relapsed after or is refractory to at least one line of salvage combination chemotherapy.
✓. Measurable disease by cross sectional imaging or evaluable disease by uptake on 123I-MIBG scan. Patients with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study.
✓. 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 ≥ 50%. Patients who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score.
✓. Creatinine ≤1.5 ULN for age, if higher, an estimated (calculated) creatinine clearance must be ≥ 60 ml/min/1.73 m2.
✓. Absolute lymphocyte count ≥ 0.25 x 10\^9/L.
Exclusion criteria
✕. Patients with only bone marrow detectable disease in the absence of measurable disease by cross sectional imaging or evaluable disease by uptake on 123I-MIBG scan.
✕. Patients with active, inoperative CNS disease including leptomeningeal disease.
What they're measuring
1
Safety of administering the ATIMP
Timeframe: 28 days
2
Number of therapeutic products generated and the number of ATIMPs infused after successful manufacture
✕. Clinically significant systemic illness or medical condition (e.g., significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.
✕. Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC.
✕. Any contraindication to the use of Anticoagulant Citrate Dextrose Solution.