health uoflLOUISVILLE, Ky. (8/8/18) — Stony Brook University, iCell Gene Therapeutics and the University of Louisville have received Food and Drug Administration clearance for an Investigational New Drug for the treatment of relapsed and refractory T-cell leukemia and lymphoma. The approach is the first to use chimeric antigen receptor engineered T-cells directed against the target protein CD4.
 
Together, Stony Brook University, the University of Louisville and iCell Gene Therapeutics expect the first in-human Phase I clinical trial to begin accruing patients before the end of 2018.
 
“We are excited to partner with the University of Louisville and iCell Gene Therapeutics to offer this innovative first-in-human CAR T cell immunotherapy clinical trial for patients who are suffering from these extremely difficult to treat T cell lymphomas and leukemias,” said Huda Salman, M.D., principal investigator for the IND and an oncologist at Stony Brook University Cancer Center. “CD4CAR T cells may prove to be a promising and novel therapy in this setting.”
 
William Tse, M.D., chief of Blood and Marrow Transplantation at the University of Louisville School of Medicine, James Graham Brown Cancer Center and UofL Physicians, is the co-principal investigator of the CD4CAR clinical trial at University of Louisville site.
 
About CD4CAR
CD4CAR is a novel development for the treatment of CD4+ T-cell malignancies. The CD4-redirected chimeric antigen receptor T-cells are engineered to express an anti-CD4scFV antibody domain.
 
CD4CAR received Orphan Drug Designation by the FDA for Peripheral T cell Leukemia in 2016. Over the past several years, CAR T-cell therapy has proven its efficacy in clinical trials for various types of leukemia, lymphoma, and myeloma.
 
CAR T-cell therapy is a type of adoptive immunotherapy. A CAR-engineered T-cell is genetically modified to express a protein on its surface with the capability to bind to a target protein on another cell. The CD4CAR is manufactured from the patient’s own cells to target CD4 expressed on tumor cells. Once these cells are infused back into a patient’s body through an IV, they multiply and attack tumor cells efficiently throughout the body.
 
About T-cell leukemias and lymphomas
Although there are clinical development programs ongoing with CAR T-cells for B-cell hematological malignancies, CD4 positive T-cell malignancies (T-cell lymphomas and T–cell acute lymphoblastic leukemia), have not been targeted by a CAR therapy in a human trial.
 
TCLs account for 15–20 percent of all non-Hodgkin’s lymphomas, while T-ALLs affect about 25 percent of ALLs in adults. These malignant entities are significantly more difficult to treat in comparison to B-cell malignancies.
 
Furthermore, T-cell malignancies almost exclusively have poorer outcomes with few exceptions, lower response rates, shorter times of disease control and survival. As a result, the standard of care for T-cell malignancies is not well established and the only potential curative approach is allogeneic blood and marrow transplant for which patients need to achieve complete disease control and to have suitable marrow donors. This leaves many patients with no curative options, making the Stony Brook, UofL and iCell collaboration a welcome development in this disease category.
 
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