NCT05990751

Multi-modular Chimeric Antigen Receptor Targeting GD2 in Neuroblastoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 neuroblastoma. The ATIMP for this study (GD2 CAR T cells) are autologous T cells, modified to express GD2 CAR (targeting GD2 on the neuroblastoma cells) and additional transgenes aiming to confer resistance to inhibition in the tumour microenvironment and to support CAR T cell function and persistence. Patients will undergo an unstimulated leucapheresis for the generation of the ATIMP which will take approximately 15 days to generate. Patients will receive lymphodepleting (LD) chemotherapy with fludarabine 30 mg/m2 administered over 4 days (Day -6 to Day -3) and cyclophosphamide 500 mg/m2 administered over 2 days (Day -4 and Day-3). Patients will be treated at one of three dose levels following LD chemotherapy as described above. The study will evaluate the feasibility of generating the ATIMP, the safety of administering ATIMP, the tolerability of the ATIMP and how effectively the CAR T cells engraft, expand and persist following administration in patients with neuroblastoma. Following infusion of the CAR T cells, patients will be monitored for between 2-4 weeks as an inpatient. Following discharge, patients will enter the interventional follow up phase and be followed up for 1 year. Patients will be seen at 6 weeks post infusion then 3 monthly until 1 year post CAR T cells infusion. If patients relapse within the first-year post CAR T cell infusion, they will come off the interventional follow up and will be followed up annually until 15 years after the CAR T infusion. After completing the 1-year interventional phase of the study, all patients, irrespective of whether they progressed or responded to treatment, will enter long term follow up until 15 years post CAR T infusion.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	GD2 CAR T cells	The GD2 CAR T cells target GD2 positive cells. The cells also express transgenes that aim to increase their resistance within the tumour microenvironment.

Timeline

• Start date: 2024-04-19
• Primary completion: 2026-12-01
• Completion: 2041-12-01
• First posted: 2023-08-14
• Last updated: 2024-05-31

Locations

1 site across 1 country: United Kingdom