This phase I trial studies the side effects and the best dose of CD30 chimeric antigen receptor (CAR)-expressing autologous T lymphocytes in treating patients with CD30+ Hodgkin lymphoma or non-Hodgkin lymphoma that has come back or does not respond to treatment. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01316146.
PRIMARY OBJECTIVES:
I. To evaluate the safety of escalating doses of autologous activated T lymphocytes (ATL), genetically modified to express an artificial chimeric antigen receptor (CAR) that targets the cluster of differentiation (CD) 30 molecule (CAR.CD30) and also contains the CD28 endodomain, in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL).
SECONDARY OBJECTIVES:
I. To measure the survival of CAR.CD30 transduced ATL in vivo.
II. To measure the anti-tumor effects of CAR.CD30 transduced ATL in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL).
OUTLINE: This is a dose-escalation study.
Patients receive CD30 CAR-expressing autologous T lymphocytes intravenously (IV) over 1-10 minutes on day 0.
After completion of study treatment, patients are followed up weekly for 4 weeks, at 6 and 8 weeks, every 3 months for 12 months, every 6 months for 4 years, and then annually thereafter for up to 15 years total.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorBarbara Savoldo