CAR T Cells

Three dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level. Each patient will receive one infusion of CAR modified T cells according to the following dosing schedule: Dose Level One: 2x10\^7 cells/m2.

To prepare the CD30.CAR T cells, research staff will take some blood from the subject. This would be drawn as two separate blood collections. Alternatively, if the subject's blood counts are low, staff may collect the cells needed to prepare T cells by a pheresis procedure. This procedure will involve placing a needle in both arms, collecting the cells over 3 to 6 hours during which the subject will be required to lie relatively still.

After the T cells have been collected, some of them will be activated stimulating them with antibodies and will then be infected with a retroviral vector (a special virus that can carries a new gene into cells) containing a new gene called anti-CD30 that will make an antibody to lymphoma cells. The trained cells are called CD30.CAR T cells. Then, the cells will be tested to make sure that they kill lymphoma cells that express the CD30 antigen and not normal cells.

The subject has a type of lymph gland cancer called Lymphoma. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs.

Both antibodies and T cells have been used to treat patients with cancers; they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them.

Live record on ClinicalTrials.gov →

• PROCUREMENT Inclusion Criteria:
• Diagnosis of relapsed/refractory HL or NHL.
• CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time)
• Hgb ≥ 7.0 (may be a transfused value)
• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
• Karnofsky or Lansky score of \> 60%

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