Overview
Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).
Description
When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.
Extra blood will be drawn to measure the persistence of CART30 in vivo.
Eligibility
Inclusion Criteria:
- Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
- Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
- Karnofsky or Lansky score greater than 60%.
- Expected survival>12 weeks.
- Creatinine<2.5mg/dl.
- ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.
- Bilirubin<2.5mg/dl.
- Pulse oximetry of >90% on room air.
- Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
- Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
- Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Exclusion Criteria:
- Active infection such as hepatitis B or C.
- Receive anti-CD30 antibody-based therapy within recent 6 weeks.
- Current use of systemic corticosteroids.
- Pregnant or lactating.
- Confirmed tumor in pulmonary and archenteric tissues.