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
Chulalongkorn University
9 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria19
- 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
- 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 Criteria5
- 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.
- 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.
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Interventions
Autologous T cells lentiviral transduced to express a B7H3-specific chimeric antigen receptor (CAR) with the addition of an IL-7 receptor alpha signaling domain, administered via central venous access catheter after lymphodepletion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06612645