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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
Bu çalışma, GPC3 proteinini taşıyan solid tümörü (solid tumor; katı organ kanseri) olan çocuklarda, interlökin-15 ve -21 ile güçlendirilmiş GPC3'e özgü CAR T hücre tedavisini (SC-CAR.GPC3xIL15.21) inceliyor. Çalışmaya, standart tedavilere dirençli veya nüks etmiş hastalığı olan çocuk hastalar katılabiliyor. Çalışma Faz 1 aşamasında yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.