# US 12,600,775 B2 · Chimeric antigen receptor T cell therapy

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- Number: US 12,600,775 B2
- Document ID: US12600775B2
- Status: Granted
- Kind: B2
- Application number: 17/091,039
- Filed: 2020-11-06
- Published: 2021-06-03
- Granted: 2026-04-14
- Earliest claimed: 2019-11-06
- Assignees: Kite Pharma, Inc.
- Applicants: Kite Pharma, Inc.
- Inventors: Adrian Bot; John Rossi
- Web page: https://patentgrep.com/patent/US12600775B2

## CPC

- C07K 16/2803: {against the immunoglobulin superfamily}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/675: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 35/545: Embryonic stem cells; Pluripotent stem cells; Induced pluripotent stem cells; Uncharacterised stem cells
- A61K 38/1774: {Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)}
- A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines}
- A61K 40/11: T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
- A61K 40/31: Chimeric antigen receptors [CAR]
- A61K 40/4211: {CD19 or B4}
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 14/70521: {CD28, CD152}
- C12N 5/0636: {T lymphocytes}
- G01N 33/505: {involving T-cells}
- G01N 33/57505: of the blood, e.g. leukaemia
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/804: {Blood cells [leukemia, lymphoma]}
- A61K 2239/38: characterised by the dose, timing or administration schedule
- A61K 2239/48: Blood cells, e.g. leukemia or lymphoma
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C07K 2319/00: Fusion polypeptide
- 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
- C12N 2501/505: CD4; CD8
- C12N 2506/11: from blood or immune system cells
- C12N 2510/00: Genetically modified cells
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Provided herein are methods for preparing, producing, processing, culturing, isolating, or making cells suitable for immune or cell therapy, and for their use in cell therapy.

## Claims

### Claim 1

A method for treating relapsed or refractory mantle cell lymphoma (MCL) in a subject in need thereof that has a Ki-67 tumor proliferation index ≥50% or presence of a TP53 mutation, comprising administering to the subject a therapeutically effective amount of a composition which comprises autologous T cells expressing an anti-CD19 chimeric antigen receptor (CAR) wherein the T cells comprise CD4+ and CD8+ CAR T cells that are prepared from peripheral blood mononuclear cells (PBMCs) by positive enrichment and partial or complete depletion of circulating cancer cells and wherein the anti-CD19 CAR comprises an anti-CD19 single-chain variable fragment (scFv) comprising the heavy chain and light chain variable regions of FMC63, a CD28 intracellular signaling region, and a CD3-zeta signaling domain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the MCL is refractory to, or has relapsed following, one or more of chemotherapy, radiotherapy, immunotherapy, an autologous stem cell transplant, or any combination thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject has received 1-5 prior treatments, optionally wherein at least one of the prior treatments is selected from autologous SCT, anti-CD20 antibody, anthracycline- or bendamustine-containing chemotherapy, and/or a Bruton Tyrosine Kinase inhibitor (BTKi).

### Claim 4 (depends on 3)

The method of claim 3, wherein the BTKi is ibrutinib or acalabrutinib.

### Claim 5 (depends on 1)

The method of claim 1, wherein the subject receives a bridging therapy after leukapheresis to obtain the PBMCs and before the consequent partial or complete depletion of circulating cancer cells.

### Claim 6 (depends on 5)

The method of claim 5, wherein the bridging therapy is selected from dexamethasone, ibrutinib, and/or acalabrutinib.

### Claim 7 (depends on 1)

The method of claim 1, wherein the subject receives a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously, both given on each of the fifth, fourth, and third days before T cell infusion.

### Claim 8 (depends on 1)

The method of claim 1, wherein the PBMC are enriched for T cells by selection for CD4+ and CD8+ cells, activated with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, and then transduced with a replication-incompetent viral vector containing a polynucleotide encoding the anti-CD19 CAR.

### Claim 9 (depends on 1)

The method of claim 1, wherein the subject is administered a dose of 1×106 to 2×106 CAR positive viable T cells per kg body weight, with a maximum of 2×108 CAR positive viable T cells.