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This study examines the safety of GPC3-CAR T cells armored with IL-15 and IL-21 in adults with GPC3-positive solid tumors. Patients aged 21 and over with confirmed GPC3 positivity in their tumors who have not responded to standard and salvage therapy may take part. The study is being conducted in Phase 1 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Procurement Inclusion Criteria: * Diagnosis of 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 ≥21 years * Lansky or Karnofsky score ≥60% * Life expectancy ≥16 weeks * Barcelona Clinic Liver Cancer Stage A, B or C (- 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 \* GPC3 expression will be evaluated by standard immunohistochemistry (IHC) at Texas Patients's Hospital/Baylor College of Medicine, Department of Pathology for all patients to meet procurement eligibility. All patients will send at least 5 unstained slides. Procurement 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 Inclusion Criteria: * Diagnosis of GPC3-positive solid tumor * Age ≥ 21 years * Barcelona Clinic Liver Cancer Stage A, B or C * Life expectancy of ≥ 12 weeks * Lansky or Karnofsky score ≥ 60% * Child-Pugh-Turcotte score \< 7 * Adequate organ function: * Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min * 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, as determined by history and physical exam * 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 Treatment Exclusion Criteria: * Pregnancy or lactation * Uncontrolled infection * Systemic steroid treatment (greater than or equal to 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)