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

NCT07148050 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

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

Interventions

BIOLOGICAL

SC-CAR.GPC3xIL15.21 CAR T cells

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

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Colleen Annesley, MD · Seattle Children's Hospital

  • Corinne Summers, MD · Seattle Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2029-04-22
Completion
2044-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148050 on ClinicalTrials.gov