Tests GPC3-targeted CAR T cells in adults with GPC3-positive solid tumors

Trial details

Who runs it

Seattle Children's Hospital

Trial code

NCT07224568

Record updated

4 November 2025

Original description

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).Read full original descriptionShow less

INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors

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.

Inclusion: 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; 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: 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); 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); 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); Treatment eligibility; Pregnancy or lactation.

Procurement Eligibility.

ClinicalTrials.gov NCT07224568