[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481094":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":29,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":20,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"University College, London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GD2 CAR T Cells","EXPERIMENTAL","Treatment with the ATIMP: GD2 CAR T-cells",[13],"Biological: GD2 CAR T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","GD2 CAR T cells","Infusion with: GD2 CAR T-cells",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"CARMIGO Trial Coordinator","CONTACT","0207 679 9599","ctc.CARMIGO@ucl.ac.uk",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":20},"Karin Straathof",[30],{"facility":31,"status":32,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Great Ormond Street Hospital","RECRUITING","London","United Kingdom","UK",{"type":37,"coordinates":38},"Point",[39,40],-0.12574,51.50853,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":20,"phoneExt":20,"email":20},"Darren Hargrave",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100481094","phase-1-car-t-cells-to-target-gd2-for-dmg-100481094",false,"NCT05544526","CAR T Cells to Target GD2 for DMG","Chimeric Antigen Receptor (CAR)-T Cells to Target GD2 for Diffuse Midline Glioma","CARMIGO","Inclusion Criteria:\n\n1. Age ≥ 2 and ≤ 16 years\n2. Tissue diagnosis of H3K27M mutant Diffuse Midline Glioma.\n3. Radiographically evident tumour restricted to the brain stem or spinal cord.\n4. At least 6 weeks following completion of radiation therapy.\n5. At least 3 weeks or 5 half-lives, whichever is shorter, after treatment with agents on other early phase clinical trial\n6. Performance status: Karnofsky (age ≥ 10 years) or Lansky (age \\\u003C 10) score ≥ 40% allowing for stable neurological deficit due to DMG\n7. Absolute neutrophil count ≥1.5 x109\u002FL and platelet count ≥ 100 x109\u002FL\n8. Total bilirubin \\\u003C 1.5 ULN and ALT \\\u003C 2.5 ULN\n9. Serum creatine \\\u003C 1.5 ULN for age.\n10. For post-pubertal subjects agreement to have a pregnancy test, use adequate contraception (if applicable)\n11. Written informed consent\n\nExclusion Criteria:\n\n1. Systemic corticosteroid therapy ≥ 0.05 mg\u002Fkg dexamethasone daily (or equivalent) at time of RQR8\u002FhuK28Z CAR T cell infusion\n2. Tumour involvement of the thalamus or supratentorial lesions, cerebellar vermis or hemispheres (pontocerebellar peduncle involvement is allowed)\n3. Clinical or radiological evidence of true tumour progression\n4. Active hepatitis B, C or HIV infection\n5. Inability to tolerate leukapheresis\n6. Pre-existing significant neurological disorder not related to DMG\n7. 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.\n8. Any contraindication to lymphodepletion or to the use of Cyclophosphamide or Fludarabine as per the local SmPC\n9. Any contraindication to the use of Anticoagulant Citrate Dextrose Solution\n10. Any contraindication to Ommaya reservoir insertion (or similar catheter)\n11. Known allergy to albumin, DMSO or EDTA\n12. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression \u002Fsystemic disease modifying agents within the last 2 years\n13. Prior treatment with investigational or approved gene therapy or cell therapy products\n14. Life expectancy \\\u003C3 months\n15. Use of rituximab (or rituximab biosimilar) within the last 3 months prior to RQR8\u002FhuK28Z CAR T cell infusion\n16. Post-pubertal subjects who are pregnant or breastfeeding","ALL","16 Years",{"count":58,"type":59},12,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","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).\n\nThe 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.",[65],"Diffuse Midline Glioma, H3 K27M-Mutant",[67,68,69],"CAR T cells","Diffuse Midline Glioma","DMG","2023-09-06",{"date":72,"type":73},"2023-09-11","ACTUAL",{"date":75,"type":73},"2023-08-15",{"date":77,"type":59},"2039-12",{"name":5,"class":6},1]