Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Recruiting now · Phase 1
Conditions studied: Solid Tumor (Excluding CNS), Liver Cell Carcinoma, Malignant Rhabdoid Tumor, Yolk Sac Tumor, Liposarcoma, Rhabdomyosarcoma, Embryonal Sarcoma of Liver, Wilms Tumor, Hepatocellular Carcinoma, Hepatoblastoma
In brief
This Phase 1, open-label, non-randomized study will enroll pediatric and young 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). A child or young adult 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
- NCT07148050
- Run by
- Seattle Children's Hospital
- People needed
- 21
- Starts
- 2025-12-22
- Expected to finish
- 2044-04-22
- Last updated by the study team
- 2026-02-17
Who can join
Age: 1 and older, up to 26. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of a solid tumor expressing GPC3
- Lansky or Karnofsky score of >=60%
- Life expectancy of >16 weeks
- 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
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:
- Lansky or 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 12 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 autoimmune or inflammatory disorder
- Live vaccines within 30 days prior to enrollment
- Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
Where it is running
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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