CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Summary

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).

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.

Conditions3

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