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
Fred Hutch Cancer Center
Seattle, Washington 98109
- Gentry King, MD(contact)206-606-1024[email protected]; [email protected]
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.