CARE T cells

Four different dosing schedules will be evaluated. The following dose levels will be evaluated: DL0: 1x10\^7/m\^2 DL1: 3x10\^7/m\^2 DL2: 1x10\^8/m\^2 DL3: 3x10\^8/m\^2 The doses are calculated according to the actual number of GPC3-CAR transduced T cells.

Approximately 18-30 subjects will participate in the treatment part of this study. Maximum of 180 mL of blood (not exceeding 3ml/kg/day) is collected from patients to grow the T cells and a retrovirus (a special virus that can insert the GPC3 CAR gene into the T cells) is used to genetically engineer them. After the CAR gene was put into the T cells, the investigators make sure that they are able to kill GPC3 positive solid tumor cells in the laboratory.

LYMPHODEPLETION CHEMOTHERAPY: Several studies suggest that the infused T cells need room to be able to increase in numbers/multiply and accomplish their functions and that this may not happen if there are too many other T cells in circulation . Because of that, participants will receive treatment with lymphodepletion chemotherapy. This chemotherapy means the participant will receive both cyclophosphamide (Cytoxan) and fludarabine.

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 CARE 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.

Live record on ClinicalTrials.gov →

• Procurement Eligibility
• 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 ≥1 year and ≤ 21 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)

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