Trial Details
Trial status:
In set-up (funded)
Recruitment start date:
Funder:
Jon Moulton Charity Trust & Abbie's Army
Sponsor:
UCL
Chief Investigator:
Dr Karin Straathof
Recruitment target:
12
EudraCT number:
N/A
Contact details:
ctc.glimps@ucl.ac.uk
Note: For enquiries only. DO NOT use for clinical referrals.
Lay summary:
GLIMPS
Glioma targeting IL13RA2/IL-15 multi-modular CAR T paediatric study
Description
Design:

A single centre, open label, phase 1 trial using the continual reassessment method (CRM) to evaluate the safety and optimal biologic dose of IL-15/06B5 CAR T cells in patients aged 2-16 years with IL13RA2+paediatric-type diffuse High-Grade Gliomas (pHGG). A total of 12 participants will be treated at the single participating site.

Treatment:

1. Leukapheresis: following registration, participants will undergo an unstimulated leukapheresis, which will be used for the manufacture of the IL-15/06B5 CAR T cells.

2. Ommaya reservoir (or similar catheter)insertion: Participants will have an intracerebroventricular catheter placed following enrolment and prior to IL-15/06B5 CAR T cell infusion to allow monitoring, and treatment, if necessary, of increased intracranial pressure(ICP) and, if eligible, for IL-15/06B5 CAR T cell administration (on Theme 2).

3. Lymphodepletion: Prior to the 1st IV CART cell infusion, participants will receive fludarabine 30mg/m2 (on days -6 to-3) and cyclophosphamide 500mg/m2 (on days -4 to -3).

4. IL-15/06B5 CAR T cell infusion: The IL-15/06B5CAR T cells will be given in two themes. All participants will receive treatment on Theme 1 (intravenous infusion) of CAR T cells at a dose assigned to the participant by TMG/CTC. 

The following dose levels will be tested:

• Dose Level 1: 10 x10^6 CAR T cells/m2

• Dose Level 2: 30 x10^6 CAR T cells/m2

• Dose Level 3: 100 x10^6 CAR T cells/m2

Participants whose disease does not respond to this intravenous infusion (or comes back (relapses) later) and in the absence of significant and/or persistent toxicity, may receive a second flat dose of 10x10^6 CART cells infusion in theme 2 (intracerebroventricular infusion delivered into the brain using Ommaya reservoir or similar catheter).

Key inclusion/exclusion criteria:

Key inclusion criteria:

  • Age ≥ 2 and ≤ 16 years
  • Tissue diagnosis of paediatric-type diffuse High-Grade Glioma 
  • Expression of IL-13RA2 in the tumour 
  • Radiographically evident tumour  
  • At least 6 weeks following completion of standard of care treatment

Key Exclusion Criteria:

  • Tissue diagnosis of infant-type hemispheric glioma
  • Tumour involvement of the thalamus or cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)
  • Clinical or radiological evidence of significant and rapid tumour progression 
  • Active hepatitis B, C or HIV infection
  • Active helminth or parasite infection
Duration of recruitment: Anticipated duration of recruitment will be 2 years. This trial is not yet open to recruitment.
Aim

To assess feasibility of generating and administering IL-15/06B5 CAR T cells to patients with pHGG, and determine the safety of the CAR T cells, as an intravenous (IV) agent (Theme 1) and in the event of non-response or partial response following IV, as an intracerebroventricular (ICV) agent (Theme 2).

To evaluate efficacy of IL-15/06B5 CAR T cells in patients with pHGG.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
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Telephone:
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