METHOD OF TREATMENT EMPLOYING THERAPEUTIC T CELL PRODUCT FROM MOBILISED DONORS
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)