๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age โฅ 2 and โค 16 years
2. Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.
3. Radiographically evident tumour restricted to the brain stem or spinal cord.
4. At least 6 weeks following completion of radiation therapy.
5. At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial
6. Performance status: Karnofsky (age โฅ 10 years) or Lansky (age \< 10) score โฅ 40% allowing for stable neurological deficit due to DMG
7. Absolute neutrophil count โฅ1.5 x109/L and platelet count โฅ 100 x109/L
8. Total bilirubin \< 1.5 ULN and ALT \< 2.5 ULN
9. Serum creatine \< 1.5 ULN for age.
10. For post-pubertal subjects agreement to have a pregnancy test, use adequate contraception (if applicable)
11. Written informed consent
Exclusion Criteria:
1. Systemic corticosteroid therapy โฅ 0.05 mg/kg dexamethasone daily (or equivalent) at time of RQR8/huK28Z CAR T cell infusion
2. Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)
3. Clinical or radiological evidence of true tumour progression
4. Active hepatitis B, C or HIV infection
5. Inability to tolerate leukapheresis
6. Pre-existing significant neurological disorder not related to DMG
7. 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.
8. Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC
9. Any contraindication to the use of Anticoagulant Citrate Dextrose Solution
10. Any contraindication to Ommaya reservoir insertion (or similar catheter)
11. Known allergy to albumin, DMSO or EDTA
12. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression /systemic disease modifying agents within the last 2 years
13. Prior treatment with investigational or approved gene therapy or cell therapy products
14. Life expectancy \<3 months
15. Use of rituximab (or rituximab biosimilar) within the last 3 months prior to RQR8/huK28Z CAR T cell infusion
16. Post-pubertal subjects who are pregnant or breastfeeding
Great Ormond Street Hospital
London, United Kingdom
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.