[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-cancers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100563167","phase-1-safety-and-efficacy-of-cmd03-car-t-cell-in-children-with-relapse-or-refractory-solid-tumors-100563167",false,"NCT06612645","Safety and Efficacy of CMD03 CAR T Cell in Children With Relapse or Refractory Solid Tumors","Safety and Efficacy of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD03) in Relapse and Refractory Pediatric Solid Tumors","CMD03","Inclusion Criteria:\n\n1. Participants must have B7-H3 positive solid tumor with measurable disease.\n\n   \\- B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) or flow cytometry using a previously obtained sample.\n2. Evidence of relapsed or refractory disease after standard first-line therapy\n3. Age 1 - 25 years\n4. Sex: Male or female\n5. Performance status: Lansky or Karnofsky score not less than 50\n6. Life expectancy not less than 12 weeks\n7. Normal organ function\n\n   * AST (SGOT) below 5 times the upper limit of normal (ULN)\n   * ALT (SGPT) below 5 times the upper limit of normal (ULN)\n   * Total bilirubin below 3 times the upper limit of normal (ULN)\n   * Creatinine below 5 times the upper limit of normal (ULN)\n   * SpO2 room air not less than 90%\n8. Prior therapy wash-out before planned leukapheresis\n\n   * Not less than 7 days post last chemotherapy\u002Fbiologic therapy administration\n   * 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy\n   * At least 30 days from most recent cellular infusion\n   * All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg\u002Fkg\u002Fday dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed\n9. Participants and\u002For legal guardians must have the ability to understand and willingness to sign a written informed consent and\u002For assent document\n\nExclusion Criteria:\n\n1. Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention\n2. Presence of primary immunodeficiency or bone marrow failure syndrome\n3. Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n4. Pregnant or breastfeeding women were excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment in this study and for four months after receiving CAR-T-cell infusion.\n5. Serologic status reflecting active HIV, hepatitis B or C infection. Participants who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to enrollment.","ALL","1 Year","25 Years",{"count":21,"type":22},9,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase 1 clinical trial to evaluate the safety and early efficacy of CAR T-cells with IL-7Ra signal targeting B7H3 in children with solid tumors patients after complete standard treatments.",[28,29],"Pediatric Cancers","Solid Tumor Pediatric",[31,32,33,34,35,36],"CAR T cell","B7H3","IL-7 receptor alpha","Chimeric antigen receptor T cell","Adoptive cellular therapy","Solid tumor pediatric","RECRUITING","2026-02-26",{"date":40,"type":41},"2026-03-02","ACTUAL",{"date":43,"type":41},"2025-04-01",{"date":45,"type":22},"2028-12-01",{"name":47,"class":48},"Chulalongkorn University","OTHER"]