Interleukin-15 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells As Immunotherapy for Patients with SOLID TUMORS (CATCH)

Description

Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CATCH T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carriesa

Trial Eligibility

Procurement Eligibility Inclusion Criteria: * Relapsed or refractory GPC3-positive\* solid tumors (as determined by immunohistochemistry with an extent score of \>=Grade 2 \[\>25% positive tumor cells\] and an intensity score of \>= 2 \[scale 0-4\]). * Age ≥18 years * Lansky or Karnofsky score ≥60% * Life expectancy ≥16 weeks * Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only) * Child-Pugh-Turcotte score \<7 (for patients with hepatocellular carcinoma only) * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Exclusion Criteria: * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only 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: * Age ≥ 18 years * Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only) * Life expectancy of ≥ 12 weeks * Lansky or Karnofsky score ≥ 60% * Child-Pugh-Turcotte score \< 7 (for patients with hepatocellular carcinoma only) * Adequate organ function: * Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min * serum AST\< 5 times ULN * total bilirubin \< 3 times ULN for age * INR ≤1.7 (for patients with hepatocellular carcinoma only) * absolute neutrophil count \> 500/μl * platelet count \> 25,000/μl (can be transfused) * Hgb ≥ 7.0 g/dl (can be transfused) * Pulse oximetry \>90% on room air * 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. Patient/guardian given copy of informed consent Exclusion Criteria: * 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) * Known HIV positivity * Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * History of organ transplantation * History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)

Study Info

Interventions

Locations Recruiting

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