IP Library Granted Patent US 12668777
Granted Patent B2
US 12668777 · App. 17/395,184 · Granted Jun 30, 2026

Chimeric antigen receptor T cells and methods of use thereof

Inventor: Gang Zhou (Martinez, GA)
Assignee: Augusta University Research Institute, Inc.
C12N5/0636A61K40/11A61K40/31A61K40/4211A61K40/4242A61P35/00A61K2239/48A61K2239/50
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Quick Facts
Patent No.
US 12668777
App. No.
17/395,184
Granted
Jun 30, 2026
Kind
B2
Abstract

Disclosed herein are engineered polyfunctional CD4 + T cells/CAR T cells and methods of their use for the treatment of cancers. One embodiment provides a method of producing polyfunctional CD4 + T cells by constitutively activating STAT5A in the cells to induce a polyfunctional phenotype. Also provided is a method of reversing exhaustion in tumor-specific CD4 + T cells by engineering the cells to express Fos, Jun, Nr4a1, or combinations thereof but not express Tox, Pdcd1, Ctla4, Haver2, Lag3, Tigit, Slam6, Nrf4a2, and administering the engineered cells to a subject.

Claims (13)

1 . A method of adoptive transfer comprising:

a) isolating CD4 + and CD8 + T cells from a subject,

b) expanding the CD4 + and CD8 + T cells ex vivo,

c) genetically engineering the CD4 + and CD8 + T cells to produce polyfunctional CD4 + and CD8 + T cells which express a cluster of differentiation 19 protein chimeric antigen receptor (CD 19CAR) and constitutively express signal transducer and activator of transcription 5 (Stat5a) by transducing the CD4 + and CD8 + T cells with SEQ ID NO: 1 or 2, and

d) administering the polyfunctional CD4 + and CD8 + T cells expressing CD19CAR and constitutively expressing Stat5a to the subject in an amount effective to induce an immune response to cancer,

wherein the subject has a hematological cancer,

wherein the polyfunctional CD4 + and CD8 + T cells expressing CD19CAR reverse exhaustion in tumor-specific CD4 + and CD8 + T cells and the constitutive STAT5a activity induces epigenetic changes and changes in expression in comparison to control CD4 + and CD8 + T cells in hematological cancer, and

wherein the polyfunctional CD4 + and CD8 + T cells expressing CD19CAR and constitutively expressing Stat5a, when administered in combination, synergistically enhances tumor infiltration and retention of CD4 + and CD8 + T cells compared to control CD4 + and CD8 + T cells in hematological cancer.

2 . The method of claim 1 , wherein the immune response is production and release of cytokines from the polyfunctional CD4 + and CD8 + T cells, wherein the cytokines are selected from the group consisting of IFNγ, IL4, IL13, and GMCSF.

3 . The method of claim 1 , wherein the polyfunctional CD4 + and CD8 + T cells are administered to the subject in an aqueous solution by parenteral administration or infusion.

4 . The method of claim 1 , wherein the polyfunctional CD4 + and CD8 + T cells are autologous.

5 . The method of claim 1 , wherein the immune response reduces or prevents tumor growth or progression, or a combination thereof, compared to untreated tumors, in the subject in need thereof.

6 . The method of claim 1 , wherein the hematologic cancer is B cell lymphoma.