# US 2025/0367237 A1 · C-kit binding proteins, chimeric antigen receptors, and uses thereof

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- Number: US 2025/0367237 A1
- Document ID: US20250367237A1
- Status: Published application
- Kind: A1
- Application number: 19/304,317
- Filed: 2025-08-19
- Published: 2025-12-04
- Earliest claimed: 2023-02-21
- Assignees: TeneoBio, Inc.
- Applicants: TeneoBio, Inc.
- Inventors: Brian Avanzino; Katherine Harris; Harbani Kaur Malik Chaudhry
- Web page: https://patentgrep.com/patent/US20250367237A1

## CPC

- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- C07K 16/2803: {against the immunoglobulin superfamily}
- 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 40/421: {Immunoglobulin superfamily}
- A61K 40/4224: {Molecules with a "CD" designation not provided for elsewhere}
- A61P 35/00: Antineoplastic agents
- C07K 14/7051: {T-cell receptor (TcR)-CD3 complex}
- C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex}
- C12N 5/0636: {T lymphocytes}
- A61K 2239/13: Antibody-based
- C07K 2317/31: multispecific
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/565: Complementarity determining region [CDR]
- C07K 2317/567: Framework region [FR]
- C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
- C07K 2317/73: Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- 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)
- 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

Single domain antibodies which specifically bind to c-Kit and c-Kit binding proteins, anti-c-Kit antibodies and antibody fragments thereof, antibody-drug conjugates, diagnostic agents, and chimeric antigen receptors (CARs) comprising the same are disclosed, along with CAR-expressing immune cells. Also disclosed are pharmaceutical compositions comprising any of the foregoing, uses of any of the foregoing in the treatment and/or diagnosis and/or monitoring of a disease associated with c-Kit expression, and uses of any of the foregoing in a stem cell transplantation preconditioning regimen.

## Claims

### Claim 1

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region in which the full set of VH CDRs 1, 2, and 3 (combined) has at least 95% sequence identity to the VH CDRs 1, 2, and 3 of any one of SEQ ID NOs: 14-18.

### Claim 2

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising:
(a) (i) a VH complementarity determining region one (CDR1) comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3;
(ii) a VH CDR2 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, or SEQ ID NO: 7; and
(iii) a VH CDR3 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 8, SEQ ID NO: 9, or SEQ ID NO: 10; or
(b) a VH CDR1 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 11; a VH CDR2 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 12; and a VH CDR3 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 13.

### Claim 3

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising:
(i) a VH complementarity determining region one (CDR1) comprising the sequence
(SEQ ID NO: 53)
G X1 T X2 X3 X4 Y A,
wherein X1 is F or L; X2 is F or I; X3 is D or S; and X4 is S or T;
(ii) a VH CDR2 comprising the sequence
(SEQ ID NO: 71)
I S X5 X6 G X7 X8 T,
wherein X5 is V or T, X6 is R or G; X7 is G or S; and X8 is S or R; and
(iii) a VH CDR3 comprising the sequence
(SEQ ID NO: 54)
A T G Y D X9 S G X10 Y Y G G F D Y,
wherein X9 is S or P; and X10 is Y or H.

### Claim 4

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising:
(i) a VH complementarity determining region one (CDR1) comprising a sequence chosen from SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3;
(ii) a VH CDR2 comprising a sequence chosen from SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, and SEQ ID NO: 7; and
(iii) a VH CDR3 comprising a sequence chosen from SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10.

### Claim 5

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising:
(a) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 1, 4, and 8, respectively;
(b) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 2, 5, and 9, respectively;
(c) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 3, 6, and 8, respectively;
(d) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 2, 7, and 10, respectively; or
(e) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 11, 12, and 13, respectively.

### Claim 6

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising the VH CDR1, VH CDR2, and VH CDR3 of any one of SEQ ID NOs: 14-18.

### Claim 7 (depends on 1, 2, 3, 4, 5, 6)

The single domain antibody according to any one of claims 1 to 6, wherein the VH CDR1, VH CDR2, and VH CDR3 sequences are present in a human VH framework.

### Claim 8

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region having at least 95% sequence identity to any one of SEQ ID NOs: 14-18.

### Claim 9

A single domain antibody which specifically binds to c-Kit, wherein the single domain antibody comprises a heavy chain variable (VH) region chosen from SEQ ID NOs: 14-18.

### Claim 10 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9)

The single domain antibody according to any one of claims 1 to 9, wherein the single domain antibody specifically binds to human c-Kit.

### Claim 11 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10)

The single domain antibody according to any one of claims 1 to 10, wherein the single domain antibody binds to human c-Kit with a KD of from about 10−9 M to about 10−6 M.

### Claim 12 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)

The single domain antibody according to any one of claims 1 to 11, wherein the single domain antibody is an isolated single domain antibody.

### Claim 13 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)

A c-Kit binding protein comprising the single domain antibody according to any one of claims 1 to 11.

### Claim 14 (depends on 13)

The c-Kit binding protein according to claim 13, wherein the c-Kit binding protein specifically binds to human c-Kit.

### Claim 15 (depends on 13, 14)

The c-Kit binding protein according to claim 13 or 14, wherein the c-Kit binding protein further specifically binds to CD3.

### Claim 16 (depends on 13, 14, 15)

The c-Kit binding protein according to any one of claims 13 to 15, wherein the c-Kit binding protein further specifically binds to human CD3.

### Claim 17 (depends on 13, 14, 15, 16)

The c-Kit binding protein according to any one of claims 13 to 16, wherein the c-Kit binding protein is an isolated monoclonal antibody.

### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)

An antibody-drug conjugate comprising the single domain antibody according to any one of claims 1 to 11.

### Claim 19 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)

An anti-c-Kit antibody comprising the single domain antibody according to any one of claims 1 to 11.

### Claim 20 (depends on 19)

The anti-c-Kit antibody according to claim 19, wherein the anti-c-Kit antibody is multi-specific.

### Claim 21 (depends on 19, 20)

The anti-c-Kit antibody according to claim 19 or 20, wherein the anti-c-Kit antibody further specifically binds to a tumor-specific antigen other than c-Kit.

### Claim 22 (depends on 19, 20, 21)

The anti-c-Kit antibody according to any one of claims 19 to 21, wherein the anti-c-Kit antibody is bispecific.

### Claim 23 (depends on 19, 20, 21, 22)

The anti-c-Kit antibody according to any one of claims 19 to 22, wherein the anti-c-Kit antibody further specifically binds to CD3.

### Claim 24 (depends on 19, 20, 21, 22, 23)

The anti-c-Kit antibody according to any one of claims 19 to 23, wherein the anti-c-Kit antibody further specifically binds to human CD3.

### Claim 25 (depends on 19, 20, 21, 22, 23, 24)

The anti-c-Kit antibody according to any one of claims 19 to 24, wherein the anti-c-Kit antibody further comprises a CD3-binding heavy chain variable (VH) region.

### Claim 26 (depends on 19, 20, 21, 22, 23, 24, 25)

The anti-c-Kit antibody according to any one of claims 19 to 25, wherein the anti-c-Kit antibody is of the IgG1 or IgG4 subtype.

### Claim 27 (depends on 19, 20, 21, 22, 23, 24, 25, 26)

The anti-c-Kit antibody according to any one of claims 19 to 26, wherein the anti-c-Kit antibody further comprises a CD3-binding heavy chain variable (VH) region that is paired with a light chain variable (VL) region.

### Claim 28 (depends on 25, 27)

The anti-c-Kit antibody according to claim 25 or 27, wherein the CD3-binding VH region comprises:
(i) a VH complementarity determining region one (CDR1) comprising a sequence having at most two amino acid modifications relative to any one of SEQ ID NOs: 20-25;
(ii) a VH CDR2 comprising a sequence having at most two amino acid modifications relative to SEQ ID NO: 26; and
(iii) a VH CDR3 comprising a sequence having at most two amino acid modifications relative to any one of SEQ ID NOs: 27-30.

### Claim 29 (depends on 28)

The anti-c-Kit antibody according to claim 28, wherein the CD3-binding VH CDR1 comprises a sequence chosen from SEQ ID NOs: 20-25.

### Claim 30 (depends on 28, 29)

The anti-c-Kit antibody according to claim 28 or 29, wherein the CD3-binding VH CDR2 comprises the sequence of SEQ ID NO: 26.

### Claim 31 (depends on 28, 29, 30)

The anti-c-Kit antibody according to any one of claims 28 to 30, wherein the CD3-binding VH CDR3 comprises a sequence chosen from SEQ ID NOs: 27-30.

### Claim 32 (depends on 25, 27, 28, 29, 30, 31)

The anti-c-Kit antibody according to any one of claim 25 or 27 to 31, wherein the full set of VH CDRs 1, 2, and 3 (combined) in the CD3-binding VH region has at least 95% sequence identity to the VH CDRs 1, 2, and 3 of any one of SEQ ID NOs: 31-48.

### Claim 33 (depends on 25, 27)

The anti-c-Kit antibody according to claim 25 or 27, wherein the CD3-binding VH region comprises:
(i) a VH complementarity determining region one (CDR1) comprising the sequence
(SEQ ID NO: 55)
G F T F X11 X12 Y A,
wherein X11 is D, A, or H; and X12 is D or N;
(ii) a VH CDR2 comprising the sequence ISWNSGSI (SEQ ID NO: 26); and
(iii) a VH CDR3 comprising the sequence
(SEQ ID NO: 56)
A K D S R G Y G X13 Y X14 X15 G GA Y,
wherein X13 is D or S; X14 is R or S; and X15 is L or R.

### Claim 34 (depends on 25, 27)

The anti-c-Kit antibody according to claim 25 or 27, wherein the CD3-binding VH region comprises the VH CDR1, VH CDR2, and VH CDR3 of any one of SEQ ID NOs: 31-48.

### Claim 35 (depends on 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)

The anti-c-Kit antibody according to any one of claims 25 to 34, wherein the VH CDR1, VH CDR2, and VH CDR3 sequences in the CD3-binding VH region are present in a human VH framework.

### Claim 36 (depends on 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)

The anti-c-Kit antibody according to any one of claims 25 to 35, wherein the CD3-binding VH region has at least 95% sequence identity to any one of SEQ ID NOs: 31-48.

### Claim 37 (depends on 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)

The anti-c-Kit antibody according to any one of claims 25 to 36, wherein the CD3-binding VH region comprises:
(a) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 20, 26, and 27, respectively;
(b) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 20, 26, and 28, respectively;
(c) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 20, 26, and 29, respectively;
(d) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 21, 26, and 28, respectively;
(e) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 22, 26, and 28, respectively;
(f) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 23, 26, and 28, respectively;
(g) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 24, 26, and 28, respectively;
(h) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 20, 26, and 30, respectively;
(i) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 25, 26, and 29, respectively; or
(j) a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 24, 26, and 29, respectively.

### Claim 38 (depends on 37)

The anti-c-Kit antibody according to claim 37, wherein the CD3-binding VH region comprises a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 20, 26, and 27, respectively.

### Claim 39 (depends on 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)

The anti-c-Kit antibody according to any one of claims 27 to 38, wherein the light chain variable region comprises the VL CDR1, VL CDR2, and VL CDR3 of SEQ ID NO: 52.

### Claim 40 (depends on 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)

The anti-c-Kit antibody according to any one of claims 27 to 39, wherein the light chain variable region comprises a VL CDR1, a VL CDR2, and a VL CDR3 comprising the sequences of SEQ ID NOs: 49, 50, and 51, respectively.

### Claim 41 (depends on 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)

The anti-c-Kit antibody according to any one of claims 27 to 40, wherein the VL CDR1, VL CDR2, and VL CDR3 sequences are present in a human VH framework.

### Claim 42 (depends on 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)

The anti-c-Kit antibody according to any one of claims 27 to 41, wherein the light chain variable region has at least 95% sequence identity to SEQ ID NO: 52.

### Claim 43 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)

The anti-c-Kit antibody according to any one of claims 19 to 42, wherein the anti-c-Kit antibody specifically binds to human c-Kit.

### Claim 44 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)

The anti-c-Kit antibody according to any one of claims 19 to 43, wherein the anti-c-Kit antibody is an isolated antibody.

### Claim 45 (depends on 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)

An antibody fragment that specifically binds to c-Kit, wherein the antibody fragment comprises a fragment of the anti-c-Kit antibody according to any one of claims 19 to 44.

### Claim 46 (depends on 45)

The antibody fragment according to claim 45, wherein the antibody fragment is a three-chain antibody-like molecule.

### Claim 47 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11)

A chimeric antigen receptor (CAR)-expressing immune cell comprising a CAR that comprises an extracellular antigen-binding domain which specifically binds to c-Kit, wherein the extracellular antigen-binding domain comprises the single domain antibody according to any one of claims 1 to 11.

### Claim 48 (depends on 47)

The CAR-expressing immune cell according to claim 47, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 2, 5, and 9, respectively.

### Claim 49 (depends on 47, 48)

The CAR-expressing immune cell according to claim 47 or claim 48, wherein the single domain antibody comprises a heavy chain variable (VH) region of SEQ ID NO: 15.

### Claim 50 (depends on 47)

The CAR-expressing immune cell according to claim 47, wherein the single domain antibody comprises a heavy chain variable (VH) region comprising a VH CDR1, a VH CDR2, and a VH CDR3 comprising the sequences of SEQ ID NOs: 11, 12, and 13, respectively.

### Claim 51 (depends on 47, 50)

The CAR-expressing immune cell according to claim 47 or claim 50, wherein the single domain antibody comprises a heavy chain variable (VH) region of SEQ ID NO: 18.

### Claim 52 (depends on 47, 48, 49, 50, 51)

The CAR-expressing immune cell according to any one of claims 47 to 51, wherein the CAR further comprises a transmembrane domain and an intracellular signaling domain.

### Claim 53 (depends on 52)

The CAR-expressing immune cell according to claim 52, wherein the CAR further comprises a hinge between the extracellular antigen binding domain and the transmembrane domain.

### Claim 54 (depends on 47, 48, 49, 50, 51, 52, 53)

The CAR-expressing immune cell according to any one of claims 47 to 53, wherein the immune cell is chosen from T cells and natural killer (NK) cells.

### Claim 55 (depends on 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)

A pharmaceutical composition comprising at least one c-Kit binding protein, antibody-drug conjugate, anti-c-Kit antibody, antibody fragment, or CAR-expressing immune cell according to any one of claims 13 to 54 and a pharmaceutically acceptable excipient.

### Claim 56 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)

A polynucleotide encoding:
the single domain antibody according to any one of claims 1 to 12; or
a chimeric antigen receptor comprising an extracellular antigen-binding domain which specifically binds to c-Kit, wherein the extracellular antigen-binding domain comprises the single domain antibody according to any one of claims 1 to 11.

### Claim 57 (depends on 13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)

A composition comprising one or more polynucleotide(s) encoding the c-Kit binding protein, anti-c-Kit antibody, or antibody fragment according to any one of claims 13 to 17 or 19 to 46.

### Claim 58 (depends on 56, 57)

A recombinant expression vector comprising the polynucleotide or composition according to claim 56 or claim 57.

### Claim 59 (depends on 58)

A host cell comprising the recombinant expression vector according to claim 58.

### Claim 60 (depends on 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)

A method of treating a disease associated with c-Kit expression in a subject in need thereof, comprising administering to the subject at least one c-Kit binding protein, antibody-drug conjugate, anti-c-Kit antibody, antibody fragment, or CAR-expressing immune cell according to any one of claims 13 to 54.

### Claim 61 (depends on 60)

The method according to claim 60, wherein the disease associated with c-Kit expression is a cancer.

### Claim 62 (depends on 60, 61)

The method according to claim 60 or claim 61, wherein the disease associated with c-Kit expression is chosen from small cell lung cancer (SCLC), gastrointestinal stromal tumors (GISTs), melanoma, and acute myeloid leukemia (AML).

### Claim 63 (depends on 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)

A method of preconditioning a subject prior to a stem cell transplant, comprising administering to the subject at least one c-Kit binding protein, antibody-drug conjugate, anti-c-Kit antibody, antibody fragment, or CAR expressing immune cell according to any one of claims 13 to 54.

### Claim 64 (depends on 63)

The method according to claim 63, wherein the subject is suffering from a condition in which a stem cell transplant is considered to be beneficial.

### Claim 65 (depends on 63, 64)

The method according to claim 63 or claim 64, wherein the subject is suffering from myelodysplastic syndrome or leukemia.

### Claim 66 (depends on 63, 64, 65)

The method according to any one of claims 63 to 65, wherein the stem cell transplant is an autologous stem cell transplant (ASCT).