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Opening soonPhase 1Ages 21 Years and up

Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors

Sponsor: Seattle Children's Hospital · NCT07224568 on ClinicalTrials.gov ↗

Conditions studied

Solid Tumor (Excluding CNS)Hepatocellular CarcinomaLiver Cell CarcinomaLiposarcomaYolk Sac TumorRhabdomyosarcoma

What it tests

  • SC-CAR.GPC3xIL15.21 CAR T cellsbiological

Where it's running1 site

See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

1. Procurement Eligibility

   Inclusion Criteria:
   * Diagnosis of a solid tumor expressing GPC3
   * Karnofsky score of \>=60%
   * Life expectancy of \>16 weeks
   * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative

   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:

* 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 3 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 bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
* Pregnancy or lactation
* 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)

Updated 2025-11-04 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.