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Immunotherapy for Pediatric Solid Tumors Using SC-CAR.GPC3xIL15.21 T Cells

This study is testing a new type of immunotherapy called SC-CAR.GPC3xIL15.21 T cells for children and young adults (ages 1 to 26) with certain solid tumors that have come back or are hard to treat. These T cells are a special kind of immune cell from your own body that are changed in the lab to recognize and attack cancer cells that have a marker called GPC3. The study will look at how safe these SC-CAR.GPC3xIL15.21 T cells are and if they can be successfully made for each patient. We will also see how well they work against the cancer. To join, you must have a solid tumor that expresses GPC3, be able to perform daily activities, and have a life expectancy of more than 16 weeks.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know what treatment you are receiving. It plans to enroll 21 participants.
What's involved
A blood sample will be collected to create your personalized CAR T cells. The safety of the SC-CAR.GPC3xIL15.21 T cells will be assessed for 28 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the safety of the treatment for 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07148050

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

Recruiting
PHASE1Ages 1–26InterventionalTreatment
Seattle Children's Hospital
~21 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:SC-CAR.GPC3xIL15.21 CAR T cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed
Measured over 28 days
+1 more outcome measured

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

Explore related trials

HepatoblastomaHepatocellular CarcinomaLiposarcomaLiver Embryonal SarcomaRhabdoid TumorRhabdomyosarcomaSolid NeoplasmWilms TumorYolk Sac TumorGlypican-3

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Colleen Annesley, MD · STUDY_DIRECTOR · Seattle Children's Hospital
  • Corinne Summers, MD · STUDY_DIRECTOR · Seattle Children's Hospital

Who to contact

Michelle Choe, MD
[email protected]
206-987-2106
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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
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.

What this trial measures

  • The number of successfully manufactured SC-CAR.GPC3xIL15.21 T cell products will be assessed28 days

    The number of successfully manufactured products will be measured

  • Establish the safety, defined by adverse events of SC-CAR.GPC3xIL15.21 T cells.28 days

    Type, frequency, severity, and duration of adverse events will be tabulated and summarized