# US 2025/0084149 A1 · Methods and compositions for dosing of allogeneic chimeric antigen receptor t cells

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- Number: US 2025/0084149 A1
- Document ID: US20250084149A1
- Status: Published application
- Kind: A1
- Application number: 18/953,634
- Filed: 2024-11-20
- Published: 2025-03-13
- Earliest claimed: 2017-10-31
- Assignees: Allogene Therapeutics, Inc.; Les Laboratoires Servier
- Applicants: Allogene Therapeutics, Inc.; Les Laboratoires Servier
- Inventors: Cyril Alkis KONTO; Amina ZINAI
- Web page: https://patentgrep.com/patent/US20250084149A1

## CPC

- C07K 14/70578: {NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95 (NGF-receptor C07K14/71, TNF-receptor C07K14/7151)}
- A61K 31/664: Amides of phosphorus acids
- A61K 31/7076: containing purines, e.g. adenosine, adenylic acid
- A61K 38/177: {Receptors; Cell surface antigens; Cell surface determinants}
- A61K 38/1774: {Immunoglobulin superfamily (e.g. CD2, CD4, CD8, ICAM molecules, B7 molecules, Fc-receptors, MHC-molecules)}
- A61K 39/001102: {Receptors, cell surface antigens or cell surface determinants}
- 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
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 14/70517: {CD8}
- C07K 16/2803: {against the immunoglobulin superfamily}
- C07K 16/2893: {against CD52}
- C07K 16/3061: {Blood cells}
- C12N 5/0636: {T lymphocytes}
- A61K 40/50: characterised by the use of allogeneic cells
- A61K 2039/505: {comprising antibodies}
- A61K 2039/507: {Comprising a combination of two or more separate antibodies}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2239/23: On/off switch
- A61K 2239/31: characterized by the route of administration
- A61K 2239/38: characterised by the dose, timing or administration schedule
- A61K 2239/48: Blood cells, e.g. leukemia or lymphoma
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/622: Single chain antibody (scFv)
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- 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 2506/11: from blood or immune system cells
- 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)

## Abstract

The present disclosure concerns dosages for the treatment of human patients susceptible to or diagnosed with a disease, such as cancer. Provided are methods for administering chimeric antigen receptor (CAR)-T cells. Also provided are compositions and articles of manufacture for use in the methods.

## Claims

### Claim 1

A method of treating a subject who has non-Hodgkin's lymphoma comprising administering to the subject allogeneic chimeric antigen receptor (CAR)-T cells (CAR-T cells) comprising an anti-human CD19 4-1BB/CD3zeta CAR, wherein the method comprises administering to the subject at least one unit dose of 120×106 cells/dose to 360×106 cells/dose, and wherein the anti-human CD19 4-1BB/CD3zeta CAR comprises an amino acid sequence of SEQ ID NO:1.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one unit dose is a unit dose of 120×106 cells/dose, 240×106 cells/dose, or 360×106 cells/dose.

### Claim 3 (depends on 2)

The method of claim 2, wherein the at least one unit dose is a unit dose of 120×106 cells/dose.

### Claim 4 (depends on 2)

The method of claim 2, wherein the non-Hodgkin's lymphoma is large B-cell lymphoma, follicular lymphoma or chronic lymphocytic leukemia.

### Claim 5 (depends on 4)

The method of claim 4, wherein the at least one unit dose is a unit dose of 120×106 cells/dose.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject has refractory and/or relapsed non-Hodgkin's lymphoma.

### Claim 7 (depends on 6)

The method of claim 6, wherein the at least one unit dose is a unit dose of 120×106 cells/dose, 240×106 cells/dose or 360×106 cells/dose.

### Claim 8 (depends on 7)

The method of claim 7, wherein the at least one unit dose is a unit dose of 120×106 cells/dose.

### Claim 9 (depends on 7)

The method of claim 7, wherein the refractory and/or relapsed non-Hodgkin's lymphoma is refractory and/or relapsed large B-cell lymphoma, refractory and/or relapsed follicular lymphoma, or refractory and/or relapsed chronic lymphocytic leukemia.

### Claim 10 (depends on 1)

The method of claim 1, wherein the CAR-T cells are CD52 deficient, or wherein the CAR-T cells comprise a mixture of CD52-deficient and CD52-positive cells.

### Claim 11 (depends on 1)

The method of claim 1, wherein the CAR-T cells comprise UCART19(CD19)CAR/RQR8+_TCRαβ-_T-cells.

### Claim 12 (depends on 1)

The method of claim 1, wherein the CAR-T cells do not express a safety switch.

### Claim 13 (depends on 1)

The method of claim 1, wherein the subject receives a first lymphodepletion regimen prior to administration of the at least one unit dose.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first lymphodepletion regimen comprises administering fludarabine and cyclophosphamide, or the first lymphodepletion regimen comprises administering fludarabine and cyclophosphamide and an anti-CD52 antibody.

### Claim 15 (depends on 14)

The method of claim 14, wherein the anti-CD52 antibody comprises the amino acid sequences of SEQ ID NO:8 and SEQ ID NO:10.

### Claim 16 (depends on 14)

The method of claim 14, wherein:
(a) fludarabine is administered at a dosage of about 30 mg/m2/day and cyclophosphamide is administered at a dosage of about 300 mg/m2/day over the course of two to three days; or
(b) fludarabine is administered at a dosage of about 30 mg/m2/day, cyclophosphamide is administered at a dosage of about 300 mg/m2/day, and anti-CD52 antibody is administered at a dosage of: about 10 to about 13 mg/day; or a total dose from about 0.3 to about 1 mg/kg, or a flat dose from about 30 to about 40 mg, from about 25 to about 60 mg or from about 100 to about 120 mg, over the course of three days.

### Claim 17 (depends on 13)

The method of claim 13, wherein the first lymphodepletion regimen is initiated between about 1 to 15 days prior to administration of the at least one unit dose.

### Claim 18 (depends on 13)

The method of claim 13, wherein the first lymphodepletion regimen is administered over the course of 1, 2, 3, 4, or 5 days.

### Claim 19 (depends on 1)

The method of claim 1, wherein the subject exhibits minimal residual disease.

### Claim 20 (depends on 5)

The method of claim 5, wherein the subject exhibits minimal residual disease.