Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 1INTERVENTIONAL

Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

1. Procurement Eligibility Who May Qualify: - Diagnosis of a solid tumor expressing GPC3 - Lansky or Karnofsky score of \>=60% - Life expectancy of \>16 weeks - willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Who May Qualify: - Lansky or Karnofsky score of \>=60% - Life expectancy of \>16 weeks - willing to sign a consent form explained to, understood by and signed by patient/guardian. - your organs (liver, kidneys, etc.) are working well enough based on blood tests - 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. - willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
1. Procurement Eligibility Inclusion Criteria: * 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 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: * 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) * Pregnancy or lactation * Uncontrolled infection * 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) * Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.

Treatments Being Tested

BIOLOGICAL

SC-CAR.GPC3xIL15.21 CAR T cells

Autologous SC-CAR.GPC3xIL15.21 T cell products infusion

Locations (1)

Seattle Children's Hospital
Seattle, Washington, United States