GPC3-targeted CAR T cells armored with IL-15 and IL-21 for pediatric non‑CNS solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label, non-randomized protocol enrolls pediatric and young adult patients with relapsed or refractory non‑CNS solid tumors that express glypican‑3 (GPC3). A blood sample is collected from each eligible patient and peripheral blood mononuclear cells are genetically modified to co‑express a GPC3‑specific CAR, interleukin‑15, interleukin‑21, and an inducible caspase‑9 safety switch (SC‑CAR.GPC3xIL15.21). The manufactured CAR T cells are infused and patients are monitored closely for safety, feasibility of manufacturing/delivery, and early signs of anti‑tumor activity. Preclinical comparisons showed that CAR T cells with IL‑15 and IL‑21 had improved tumor killing versus CAR T cells without those cytokines, and the product is investigational and not FDA approved.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Michelle Choe, MD
• Email: immunotherapy@seattlechildrens.org
• Phone: 206-987-2106

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IL-15 and IL-21–armored GPC3-CAR T cell therapy for adults with GPC3-positive solid tumors

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  Recruiting Phase 1 Baylor College of Medicine · Houston, Texas · NCT06198296

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• Combining vorinostat with chemotherapy for relapsed solid tumors and CNS cancers

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• Personalized B7-H3 CAR T cells combined with PRAME antigen-specific T cells for relapsed embryonal tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.