Tests CAR T cells in children with solid tumors that returned or resisted treatment

Trial details

Who runs it

Chulalongkorn University

Trial code

NCT06612645

Record updated

2 March 2026

Original description

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.Read full original descriptionShow less

Safety and Efficacy of B7H3 With IL-7 Receptor Alpha Signaling Chimeric Antigen Receptor T Cell (CMD03) in Relapse and Refractory Pediatric Solid Tumors

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.

Inclusion: Participants must have B7-H3 positive solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) or flow cytometry using a previously obtained sample; Evidence of relapsed or refractory disease after standard first-line therapy; Age 1 - 25 years; Sex: Male or female; Performance status: Lansky or Karnofsky score not less than 50; Life expectancy not less than 12 weeks; Normal organ function; AST (SGOT) below 5 times the upper limit of normal (ULN); ALT (SGPT) below 5 times the upper limit of normal (ULN); Total bilirubin below 3 times the upper limit of normal (ULN); Creatinine below 5 times the upper limit of normal (ULN); SpO2 room air not less than 90%; Prior therapy wash-out before planned leukapheresis; Not less than 7 days post last chemotherapy/biologic therapy administration; 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy; At least 30 days from most recent cellular infusion; All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/kg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed; Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document.

Exclusion: 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; Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention; Presence of primary immunodeficiency or bone marrow failure syndrome; 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/social situations that would limit compliance with study requirements; 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.

ClinicalTrials.gov NCT06612645