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

RecruitingPhase 1Ages 1 Year - 26 YearsAllSeattle Children's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ€ข Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections) * Pregnancy or lactation * Uncontrolled infection * Systemic steroid treatment (โ‰ฅ 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.
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What it tests

  • SC-CAR.GPC3xIL15.21 CAR T cells
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Where

1 site
Seattle Children's Hospital
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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