Recruiting
Phase 1

SC-CAR.GPC3xIL15.21

Sponsor:

Seattle Children's Hospital

Code:

NCT07148050

Conditions

Solid Tumor (Excluding CNS)

Liver Cell Carcinoma

Malignant Rhabdoid Tumor

Yolk Sac Tumor

Liposarcoma

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Not accepted

Interventions

SC-CAR.GPC3xIL15.21 CAR T cells

Study Details

Brief 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

Study ID

NCT07148050

Start date

Dec 22, 2025

Status verified date

Feb, 2026

Completion date

Apr 22, 2044

Anticipated

Primary completion date

Apr 22, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 26

Healthy Volunteers: Not accepted

1. Procurement Eligibility

Inclusion Criteria:
  • Diagnosis of a solid tumor expressing GPC3
  • Lansky or Karnofsky score of >=60%
  • Life expectancy of >16 weeks
  • Informed consent explained to, understood by and signed by patient/guardian.

For patients with hepatocellular carcinoma only:
  • Barcelona Liver Cancer Stage A, B or C
  • Child-Pugh Turcotte Score <7

Exclusion Criteria:
  • History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.

  • History of organ transplantation
  • Known HIV positivity
  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
2. Treatment eligibility

Inclusion Criteria:

  • Lansky or Karnofsky score of >=60%
  • Life expectancy of >16 weeks
  • Informed consent explained to, understood by and signed by patient/guardian.
  • Adequate organ function
  • Adequate laboratory values
  • Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
  • Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
  • Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.
  • Informed consent explained to, understood by and signed by patient/guardian.

For patients with hepatocellular carcinoma only:

  • Barcelona Liver Cancer Stage A, B or C
  • Child-Pugh Turcotte Score <7

Exclusion Criteria:

  • History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.

  • History of organ transplantation
  • Known HIV positivity
  • Active autoimmune or inflammatory disorder
  • Live vaccines within 30 days prior to enrollment

• Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
  • Pregnancy or lactation
  • Uncontrolled infection
  • Systemic steroid treatment (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)
  • Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SC-CAR.GPC3xIL15.21 T cells

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

Interventions

SC-CAR.GPC3xIL15.21 CAR T cells

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

Primary outcome measure

  • The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed [ Time Frame: 28 days ]
  • Establish the safety, defined by adverse events of SC-CAR.GPC3xIL15.21 T cells. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Michelle Choe, MD

206-987-2106immunotherapy@seattlechildrens.org

Andras Heczey, MD

Andras.Heczey@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Michelle Choe, MD

206-987-2106michelle.choe@seattlechildrens.org

Andras Heczey, MD

andras.heczey@seattlechildrens.org

Principal Investigator:

Michelle Choe, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • CAR T cell
  • Pediatric
  • Young Adult
  • Non-CNS Tumor
  • Liver Cancer
  • Solid Tumor
  • GPC3
  • Glypican

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-02-17.