RecruitingPhase 1NCT07148050

Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells


Sponsor

Seattle Children's Hospital

Enrollment

21 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells). A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.


Eligibility

Min Age: 1 YearMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR T-cell therapy — a treatment where your own immune cells are engineered to fight cancer — targeting a protein called GPC3 in children and young adults with solid tumors. The engineered cells are also "armed" with proteins (interleukins 15 and 21) to help them work better. **You may be eligible if...** - You are a child or young adult with a solid tumor that expresses a protein called GPC3 - You have reasonable physical functioning (Lansky or Karnofsky score 60% or above) - Your expected life expectancy is more than 16 weeks - If you have liver cancer specifically, it must be at Barcelona stage A, B, or C, with adequate liver function **You may NOT be eligible if...** - You have a known allergy to mouse-derived proteins - You have had an organ transplant - You are HIV positive - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSC-CAR.GPC3xIL15.21 CAR T cells

Autologous SC-CAR.GPC3xIL15.21 T cell products infusion


Locations(1)

Seattle Children's Hospital

Seattle, Washington, United States

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NCT07148050


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