Multi-modular Chimeric Antigen Receptor Targeting GD2 in Neuroblastoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 16
Healthy Volunteers: f
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• 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.

• For post-pubertal subjects agreement to have a pregnancy test, use adequate contraception (if applicable).

⁃ Written informed consent.

Locations
Other Locations
United Kingdom
Great Ormond Street Hospital
RECRUITING
London
Contact Information
Primary
MAGNETO Trial Coordinator
ctc.magneto@ucl.ac.uk
+442076799379
Backup
Karin Straathof
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2041-12
Participants
Target number of participants: 12
Treatments
Experimental: GD2 CAR T cells
Treatment with GD2 CAR T cells
Sponsors
Leads: University College, London

This content was sourced from clinicaltrials.gov