# US 12,178,872 B2 · Regulatory T cell expressing a chimeric antigen receptor

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- Number: US 12,178,872 B2
- Document ID: US12178872B2
- Status: Granted
- Kind: B2
- Application number: 16/962,755
- Filed: 2019-01-17
- Published: 2020-11-12
- Granted: 2024-12-31
- Earliest claimed: 2018-01-19
- Assignees: Miltenyi Biotec GmbH; Charite-Universitatsmedizin Berlin
- Applicants: Miltenyi Biotec B.V. & Co. KG; Charite-Universitätsmedizin Berlin
- Inventors: Anna Nowak; Dominik Lock; Andrew Kaiser; Alexander Scheffold
- Web page: https://patentgrep.com/patent/US12178872B2

## CPC

- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance}
- A61K 39/001: {Preparations to induce tolerance to non-self, e.g. prior to transplantation}
- A61K 40/22: Immunosuppressive or immunotolerising
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/40: characterised by antigens that are targeted or presented by cells of the immune system
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 14/70517: {CD8}
- C07K 14/70521: {CD28, CD152}
- C07K 14/70578: {NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95 (NGF-receptor C07K14/71, TNF-receptor C07K14/7151)}
- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- C12N 5/0637: {Immunosuppressive T lymphocytes, e.g. regulatory T cells or Treg}
- A61K 2035/122: {for inducing tolerance or supression of immune responses}
- A61K 2239/22: Intracellular domain
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2319/02: containing a signal sequence
- C07K 2319/03: containing a transmembrane segment
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- C07K 2319/33: fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention provides a regulatory T (Treg) cell expressing an antigen chimeric receptor (CAR) comprising a) at least one antigen binding domain, b) a transmembrane domain, and c) a cytoplasmic signaling domain comprising at least one primary cytoplasmic signaling domain and at least the co-stimulatory signaling domain of CD137, wherein said antigen binding domain specifically binds an antigen that is expressed on the surface of a target cell or a tag of a tagged polypeptide that binds to an antigen expressed on the surface of a target cell or a soluble antigen. Compositions comprising said Treg cells, and methods of enrichment and analysis of activated Tregs that express said CAR are also disclosed.

## Claims

### Claim 1

A combination of pharmaceutical compositions comprising
i) a population of human Treg cells expressing a CAR together with a pharmaceutical acceptable carrier, the CAR comprising
a) at least one antigen binding domain,
b) a transmembrane domain,
c) a cytoplasmic signaling domain comprising at least one primary cytoplasmic signaling domain and at least the co-stimulatory signaling domain of CD137, wherein said at least one antigen binding domain specifically binds dextran; and
ii) a dextran molecule that is not conjugated to an antibody or another attachment structure which allows specific targeting of the dextran to cells or tissue matrix surfaces in vivo,
thereby allowing the activation of said Treg cell upon binding of dextran to said at least one antigen binding domain of said CAR.

### Claim 2 (depends on 1)

The composition according to claim 1 for treatment of an autoimmune disease, allergy, transplant rejection, graft versus host disease, chronic inflammatory diseases, inflammatory bowel diseases, or a chronic infection by virus, bacteria, or parasite.