Method of treatment employing therapeutic t cell product from mobilised donors

Abstract

The present disclosure provides a method of treating a human patient in need thereof with immune reconstitution therapy by administering a therapeutically effective amount of therapeutic T cell population selected and/or expanded from a mobilised blood sample or a mobilised apheresis sample, wherein selection is on the basis of a steady state marker and/or an activation marker optionally followed by expansion, or expansion is in the presence of antigen, such as a viral antigen. It also extends to methods of generating said therapeutic T cell populations and the product obtainable therefrom.

1 . A method of treating a post-haematopoietic stem cell transplantation human patient in need thereof with immune reconstitution therapy by administering a therapeutically effective amount of therapeutic T cell population selected and/or expanded from a mobilised blood sample or a mobilised apheresis sample, wherein selection is on the basis of a steady state marker and/or an activation marker optionally followed by expansion, or expansion is in the presence of antigen, such as a viral antigen. 
     
     
         2 . (canceled) 
     
     
         3 . A method according to  claim 1 , wherein the T cell population is an antigen-specific T cell population. 
     
     
         4 . A method according to  claim 3 , wherein the antigen-specific T cell population is specific a virus for example selected from the group comprising cytomegalovirus, adenovirus, varicella zoster virus, BK virus, human papillomavirus, hepatitis B virus, hepatitis C virus, Epstein-Barr virus, Kaposi's sarcoma-associated herpes virus and human T-lymphotropic virus, such as cytomegalovirus or adenovirus. 
     
     
         5 . A therapeutic T cell population selected and/or expanded from a mobilised blood sample or mobilised apheresis or pharmaceutical composition comprising same, wherein selection is on the basis of a steady state marker and/or an activation marker optionally followed by expansion, or expansion is in the presence of antigen, such as a viral antigen. 
     
     
         6 . (canceled) 
     
     
         7 . A therapeutic T cell population or pharmaceutical composition comprising same according to  claim 5 , wherein the T cell population is an antigen specific T-cell population. 
     
     
         8 . A therapeutic T cell population or pharmaceutical composition comprising same according to  claim 7 , wherein the antigen-specific T cell population is specific a virus for example selected from the group comprising cytomegalovirus, adenovirus, varicella zoster virus, human papillomavirus, hepatitis B virus, hepatitis C virus, BK virus, Epstein-Barr virus, Kaposi's sarcoma-associated herpes virus and human T-lymphotropic virus, such as cytomegalovirus or adenovirus. 
     
     
         9 . A therapeutic T cell population or pharmaceutical composition according to any one of  claim 5 ,  7 , or  8 , wherein the population is directly selected on the basis of a steady state marker namely the T cell receptor, for example by reversible ligation of the T cell receptor by specific HLA:peptide complexes, in particular Tetra, Penta and/or Hexa streptamers. 
     
     
         10 . A therapeutic T cell population or pharmaceutical composition according to any one of  claims 5 ,  7 , or  8 , wherein the activation marker is a cell surface marker that is upregulated as a consequence of antigen stimulation, for example selected from the group comprising CD25, CD69, CD137 and CD154. 
     
     
         11 . A therapeutic T cell population or pharmaceutical composition according to any one of  claims 5 ,  7 , or  8 , wherein the T cell product is an expanded T cell product, in particular expanded in an antigen specific manner. 
     
     
         12 . A therapeutic T cell population or pharmaceutical composition according to any one of  claims 5 ,  7 , or  8 , wherein the population is substantially negative for cells with the CD25 marker. 
     
     
         13 . A therapeutic T cell population or pharmaceutical composition according to any one of  claims 5 ,  7 , or  8 , wherein the T cell population is allogeneic. 
     
     
         14 - 28 . (canceled)