Actively Recruiting
CAR T Cells to Target GD2 for DMG
Led by University College, London · Updated on 2023-09-11
12
Participants Needed
1
Research Sites
850 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CAR T Cells to Target GD2 for DMG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 16 years
- Diagnosis of H3K27M mutant Diffuse Midline Glioma confirmed by tissue
- Tumor visible on scans and located only in the brain stem or spinal cord
- At least 6 weeks since completing radiation therapy
- At least 3 weeks or 5 half-lives since treatment on other early phase clinical trials
- Karnofsky or Lansky performance score of 40% or higher, allowing for stable neurological deficits from DMG
- Absolute neutrophil count of at least 1.5 x10^9/L and platelet count of at least 100 x10^9/L
- Total bilirubin less than 1.5 times the upper limit of normal and ALT less than 2.5 times the upper limit of normal
- Serum creatinine less than 1.5 times the upper limit of normal for age
- Agreement to pregnancy testing and use of contraception if post-pubertal and applicable
- Written informed consent provided
You will not qualify if you...
- Taking systemic corticosteroids at doses of 0.05 mg/kg dexamethasone daily or higher at the time of CAR T-cell infusion
- Tumor involvement in the thalamus, supratentorial lesions, cerebellar vermis, or hemispheres (pontocerebellar peduncle involvement allowed)
- Evidence of true tumor progression clinically or on imaging
- Active hepatitis B, hepatitis C, or HIV infection
- Unable to tolerate leukapheresis procedure
- Significant neurological disorders not related to DMG
- Serious systemic illnesses or medical conditions that could interfere with safety or treatment assessment
- Contraindications to lymphodepleting chemotherapy (cyclophosphamide or fludarabine)
- Contraindications to anticoagulant citrate dextrose solution
- Contraindications to Ommaya reservoir or similar catheter insertion
- Known allergies to albumin, DMSO, or EDTA
- Primary immunodeficiency or autoimmune disease requiring systemic immunosuppression in the past 2 years
- Prior treatment with gene or cell therapy products
- Life expectancy less than 3 months
- Use of rituximab or similar drugs within 3 months prior to CAR T-cell infusion
- Pregnant or breastfeeding if post-pubertal
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Great Ormond Street Hospital
London, United Kingdom
Actively Recruiting
Research Team
C
CARMIGO Trial Coordinator
CONTACT
K
Karin Straathof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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