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A method for treating a patient comprising: (a) providing a composition comprising a population of T cells expressing both a chimeric antigen receptor (CAR) and a T cell receptor specific for a cytomegalovirus (CMV) antigen; (b) administering the composition to the patient; and (c) administering to the patient a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein 1E2 (e5) either prior to or subsequent to administering the composition comprising a population of T cells to the patient is described.

Titel:	Use of Triplex CMV Vaccine in CAR T Cell Therapy
Link:	View record in USPTO Patent Applications (Volltext)
Veröffentlichung:	2022
Medientyp:	Patent
Sonstiges:	Nachgewiesen in: USPTO Patent Applications Sprachen: English Document Number: 20220378911 Publication Date: December 1, 2022 Appl. No: 17/572496 Application Filed: January 10, 2022 Claim: 1-50. (canceled) Claim: 51. A method for treating a patient comprising: (a) providing a composition comprising a population of T cells expressing both a chimeric antigen receptor (CAR) and a T cell receptor specific for a cytomegalovirus (CMV) antigen; (b) administering the composition of part (a) to the patient; and (c) administering to the patient a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5). Claim: 52. The method of claim 51, wherein the viral vector of part (a) is a MVA virus. Claim: 53. The method of claim 52, wherein expression of (i) CMV pp65 and (ii) the fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5) is under the control of mH5 promoter. Claim: 54. The method of claim 51, wherein the patient is CMV-seronegative prior to treatment. Claim: 55. The method of claim 51, wherein the patient is CMV-seropositive prior to treatment. Claim: 56. The method of claim 51, wherein the CAR is targeted to CD19. Claim: 57. The method of claim 51, wherein the viral vector is administered to the patient both prior to and subsequent to the administration of the composition comprising a population of T cells. Claim: 58. The method of claim 51, wherein the step of providing a population of T cells expressing a CAR and a T cell receptor specific for a CMV antigen comprises: (a1) providing PBMC or a T cell subpopulation from a CMV-seropositive human donor; (a2) exposing the PBMC or the T cell subpopulation of part (a1) to at least one CMV antigen; (a3) treating the exposed cells of part (a2) to produce a population of cells enriched for cells specific for CMV; and (a4) transducing at least a portion of the enriched population of cells of part (a3) with a vector expressing a CAR. Claim: 59. The method of claim 58, wherein the step of treating the exposed cells to produce a population of cells enriched for cells specific for CMV comprises treating the cells to produce a population of cells enriched for cells expressing an activation marker. Claim: 60. The method of claim 51, wherein the step of providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen further comprises: (a1) administering a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5) to a human donor to convert a CMV-seronegative human donor to one containing T cells responsive to CMV antigens pp65, IE1 and IE2; (a2) obtaining PBMC from the CMV-seropositive human donor of (a1); (a3) exposing the PBMC of (a2) to at least one CMV antigen; (a4) treating the exposed cells of (a3) to produce a population of cells enriched for stimulated cells specific for CMV; and (a5) transducing at least a portion of the enriched population of cells of (a4) with a vector expressing a CAR, thereby providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen. Claim: 61. The method of claim 51, wherein the step of providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen comprises: (a1) administering a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5) to a CMV-positive human donor; (a2) obtaining PBMC from the CMV-seropositive human donor of (a1); (a3) exposing the PBMC of (a2) to at least one CMV antigen; (a4) treating the exposed cells of (a3) to produce a population of cells enriched for stimulated cells specific for CMV; (a5) transducing at least a portion of the enriched population of cells of (a4) with a vector expressing a CAR, thereby providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen. Claim: 62. A method for preparing T cells expressing a CAR and a T cell receptor specific for a CMV antigen, the method comprising: (a) administering a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5) to a CMV-positive human donor; (b) obtaining PBMC from the CMV-seropositive human donor; (c) exposing the PBMC to at least one CMV antigen; (d) treating the exposed cells to produce a population of cells enriched for stimulated cells specific for CMV; and (e) transducing at least a portion of the enriched population of cells with a vector expressing a CAR, thereby providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen. Claim: 63. A method for preparing T cells expressing a CAR and a T cell receptor specific for a CMV antigen, the method comprising: (a) administering a viral vector encoding: (i) CMV pp65 and (ii) a fusion protein comprising exon 4 of CMV protein IE1 (e4) and exon 5 of CMV protein IE2 (e5) to a CMV-positive human donor; (b) obtaining PBMC from the CMV-seropositive human donor; (c) (b) exposing the PBMC to at least one CMV antigen; (d) treating the exposed cells to produce a population of cells enriched for stimulated cells specific for CMV; and (e) transducing at least a portion of the enriched population of cells with a vector expressing a CAR, thereby providing a population of T cell expressing a CAR and a T cell receptor specific for a CMV antigen. Claim: 64. The method of claim 51, wherein the CAR is selective for an antigen selected from: CD19, CD123, CS1, BCMA, CD44v6, CD33, CD22, IL-13α2, PSA, HER-2, EGFRv3, CEA, and C7R. Claim: 65. The method of claim 51, wherein the CAR comprises: a scFv selective for a non-CMV antigen; a hinge/linker region; a transmembrane domain; a co-signaling domain; and CD3 ζ signaling domain. Claim: 66. The method of claim 65, wherein the co-signaling domain is selected from a CD28 co-signaling domain and a 4-IBB co-signaling domain. Claim: 67. The method of claim 65, wherein the transmembrane domain is selected from a CD28 transmembrane domain and a CD4 transmembrane Current International Class: 61; 61; 61; 61; 12; 12

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Use of Triplex CMV Vaccine in CAR T Cell Therapy