Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors
Starting soon · Phase 1
Conditions studied: Solid Tumor (Excluding CNS), Hepatocellular Carcinoma, Liver Cell Carcinoma, Liposarcoma, Yolk Sac Tumor, Rhabdomyosarcoma
In brief
This Phase 1, open-label, non-randomized study will enroll 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). An adult participant 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.
Key facts
- Study ID
- NCT07224568
- Run by
- Seattle Children's Hospital
- People needed
- 21
- Starts
- 2026-04-01
- Expected to finish
- 2045-08-01
- Last updated by the study team
- 2025-11-04
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
- 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)
Where it is running
- Fred Hutch Cancer Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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