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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT07148050
Phase
PHASE1
Status
Recruiting
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Conditions

  • Embryonal Sarcoma of Liver
  • Hepatoblastoma
  • Hepatocellular Carcinoma
  • Liposarcoma
  • Liver Cell Carcinoma
  • Malignant Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Solid Tumor (Excluding CNS)
  • Wilms Tumor
  • Yolk Sac Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • SC-CAR.GPC3xIL15.21 CAR T cells — BIOLOGICAL
    Autologous SC-CAR.GPC3xIL15.21 T cell products infusion

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Feb 2026
Primary completion
Apr 22, 2029
Completion
Apr 22, 2044

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SC-CAR.GPC3xIL15.21 T cells
    Autologous SC-CAR.GPC3xIL15.21 T cell product will be infused as a single infusion.

Primary Outcome Measure

The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Michelle Choe, MD
[email protected]
206-987-2106
Andras Heczey, MD
[email protected]
Michelle Choe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Seattle Children's Hospital· Seattle, WA

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