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 Blood, 15 September 2008, Vol. 112, No. 6, pp. 2261-2271.
Prepublished online as a Blood First Edition Paper on May 28, 2008; DOI 10.1182/blood-2007-12-128843.

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CLINICAL TRIALS AND OBSERVATIONS

Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells

Brian G. Till1,2, Michael C. Jensen3, Jinjuan Wang1, Eric Y. Chen1, Brent L. Wood4, Harvey A. Greisman4, Xiaojun Qian1, Scott E. James1, Andrew Raubitschek5, Stephen J. Forman6, Ajay K. Gopal1,2, John M. Pagel1,2, Catherine G. Lindgren2, Philip D. Greenberg1,2, Stanley R. Riddell1,2, and Oliver W. Press1,2

1 Clinical Research Division of the Fred Hutchinson Cancer Research Center, Seattle, WA; 2 Department of Medicine, University of Washington, Seattle; 3 Department of Pediatric Hematology-Oncology, City of Hope National Medical Center and Beckman Research Institute, Duarte, CA; 4 Department of Laboratory Medicine, University of Washington, Seattle; and 5 Department of Radioimmunotherapy and 6 Division of Hematology and HCT, City of Hope National Medical Center and Beckman Research Institute, Duarte, CA

Adoptive immunotherapy with T cells expressing a tumor-specific chimeric T-cell receptor is a promising approach to cancer therapy that has not previously been explored for the treatment of lymphoma in human subjects. We report the results of a proof-of-concept clinical trial in which patients with relapsed or refractory indolent B-cell lymphoma or mantle cell lymphoma were treated with autologous T cells genetically modified by electroporation with a vector plasmid encoding a CD20-specific chimeric T-cell receptor and neomycin resistance gene. Transfected cells were immunophenotypically similar to CD8+ effector cells and showed CD20-specific cytotoxicity in vitro. Seven patients received a total of 20 T-cell infusions, with minimal toxicities. Modified T cells persisted in vivo 1 to 3 weeks in the first 3 patients, who received T cells produced by limiting dilution methods, but persisted 5 to 9 weeks in the next 4 patients who received T cells produced in bulk cultures followed by 14 days of low-dose subcutaneous interleukin-2 (IL-2) injections. Of the 7 treated patients, 2 maintained a previous complete response, 1 achieved a partial response, and 4 had stable disease. These results show the safety, feasibility, and potential antitumor activity of adoptive T-cell therapy using this approach. This trial was registered at www.clinicaltrials.gov as #NCT00012207 [ClinicalTrials.gov] .


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