NCT07224568Not yet recruitingPhase 1
Cytokine Armored GPC3 Specific Chimeric Antigen Receptor Expressing T-cells in Adults With Solid Tumors
INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors
Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- First submitted
- 28 Oct 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Aug 2030
- Lead sponsor
- Seattle Children's Hospital
- Diseases
- Liver and biliary tract cancer, Sarcoma
- NCT number
- NCT07224568
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 21
- From 1 Apr 2026 to the primary completion date, 31 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- Treatment eligibility
- Pregnancy or lactation
Who the study is looking for
- 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
Criteria the registry did not label
- Procurement Eligibility
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutch Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.