CAR-T cell

Daily x 3 doses on Day -3, -2, -1 300 mg/m2 IV infusion (200 mg/m\^2 in Dose Level -1)

Daily x 2 doses on Day -2 and -1 30 mg/m\^2 IV infusion administered following cyclophosphamide

Background: * Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the second leading cause of cancer-associated mortality with an average life expectancy of 6-9 months * Despite the success of several studies showing efficacy in treating HCC, most clinical trials have failed to prove a survival advantage. * Adoptive T-cell therapy exploits the natural ability of T-cells to recognize and eliminate their target. * GPC3 is a cell surface protein that is expressed in nearly all HCC yet is undetectable in normal adult hepatic tissues. * GPC3 is also expressed strongly in some non-HCC solid tumor malignancies. * We want to evaluate the role of GPC3 targeted chimeric antigen receptor (CAR)-T cells in advanced GPC3 expressing HCC as well as other advanced solid tumor malignancies with GPC3 expression.

Background: A new cancer treatment takes a person s own T cells, modifies them in a laboratory so they can better fight cancer cells, and then gives them back to the person. Researchers want to see if this treatment can help people with a certain types of cancer. Objective: To see if a personalized immune treatment, anti-GPC3 CAR-T cells, is safe. Eligibility: Adults aged 18 years and older who have Glypican-3 (GPC3) positive solid tumor malignancy.

Design: Participants will be screened with the following: Blood and urine tests Medical history Physical exam Heart function tests Review of their symptoms and their ability to perform their normal activities Tumor biopsy Imaging scan of the chest, abdomen, and pelvis Participants will have leukapheresis. They may have an IV (intravenous catheter, a small tube put into an arm vein) inserted into each arm or get a central line. Blood will be removed.

Live record on ClinicalTrials.gov →

• Histopathological confirmation of HCC or other solid tumor malignancy by the NCI Laboratory of Pathology
• have progressed on at least 1 prior line of treatment
• -been intolerant of at least 1 prior line of treatment.
• Participants must have at least 1 focus of disease that is amenable to mandatory tumor biopsy prior to study treatment initiation to determine tumor GPC3 expression and be willing to undergo this. Ideally, the biopsied lesion should not be one of the target measurable lesions, although this can be up to the discretion of the investigators.
• Tumor must have GPC3 positivity of \>= 25% by immunohistochemistry on freshly collected biopsy
• Participants must have at least 1 measurable lesion by RECIST version 1.1

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.