Method for preparing immune cells
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- ABELZETA INC
- Filing Date
- 2026-02-27
- Publication Date
- 2026-06-09
Smart Images
Figure 2026094301000026 
Figure 2026094301000027 
Figure 2026094301000028
Abstract
Claims
1. A method for culturing genetically modified immune cells, (a) To provide a sample containing immune cells, (b) Optionally, wash the sample to obtain pre-treated immune cells, (c) Selecting the pre-treated immune cells to obtain concentrated immune cells, (d) Activate the concentrated immune cells with microbeads coated with an activator. To obtain activated immune cells, (e) Genetically modify the activated immune cells to obtain genetically modified immune cells. That thing, (f) A method comprising: increasing the gene-modified immune cells.
2. The microbeads have a diameter in the range of about 1 μm to about 10 μm, as described in claim 1. The method.
3. The microbeads have a diameter in the range of about 2 μm to about 8 μm, as described in claim 2. method.
4. The microbeads have a diameter in the range of about 4 μm to about 5 μm, as described in claim 3. method.
5. In step (d), the activation occurs in a range of approximately 0.1 to approximately 10 micro The method according to claim 1, performed in a bead-to-cell ratio.
6. In step (d), the activation is performed in the range of approximately 0.5 to approximately 5 microbits. The method according to claim 5, performed in terms of a ratio of cells to a ratio.
7. In step (d), the activation is performed on microbeads in the range of about 1 to about 2. The method according to claim 5, performed on a cell-to-cell basis.
8. The activator may be an antibody or a fragment thereof, a cytokine, a recombinant costimulatory molecule, or a small drug inhibitor. (small drug inhibitor), and groups consisting of combinations thereof. The method according to claim 1, selected from the above.
9. The claim states that the activator is an anti-CD3 and / or anti-CD28 antibody or a fragment thereof. The method described in 1.
10. In step (d), the activation is performed for approximately 16 to 48 hours. The method according to claim 1.
11. Steps (d), (e), and (f) are completed in approximately 2 to 5 days. The method according to claim 1.
12. Steps (d), (e), and (f) are completed in approximately 3 to 4 days. The method according to claim 11.
13. The method according to claim 1, wherein all steps of the method are carried out over approximately 2 to 5 days.
14. The method according to claim 13, wherein all steps of the method are carried out over approximately 3 to 4 days.
15. Steps (c) to (f) are performed in a closed, sterile system, as described in claim 1. Method of loading.
16. Claim 1, wherein all steps of the above method are performed in a closed, sterile system. Method of description.
17. The method according to claim 1, wherein the immune cells are T cells or a subset of T cells.
18. In step (d), the activation occurs approximately 0.5 × 10 ６ cells / ml ~ approx. 10 x 10 ６ The method according to claim 1, wherein the immune cell density is in the range of cells / ml.
19. In step (d), the activation occurs approximately 2 × 10 ６ cells / ml ~ approx. 3x 10 ６ The method according to claim 18, wherein the immune cell density is in the range of cells / ml.
20. In step (e), the gene modification is transduction or trans The method according to claim 1, which involves performing a specific action.
21. In step (e), the gene modification is performed on the activated immune cells, Polynucleotides encoding chimeric antigen receptors (CARs) or T cell receptors (TCRs) The method according to claim 1, which includes introducing a
22. In step (e), the gene modification is performed on the activated immune cells Antivirus vectors, gamma-retrovirus vectors, alpha-retrovirus vectors The method according to claim 1, comprising transduction with a vector or adenovirus vector. 。
23. In step (e), the gene modification is performed on the activated immune cells The method according to claim 1, comprising transduction using a thivirus vector.
24. In step (b), the washing process results in a final HSA concentration of 0.1% to 30%. The method according to claim 1, comprising using a human serum albumin (HSA) solution having 。
25. In step (b), the washing process results in a final HSA concentration of 0.1% to 10%. The method according to claim 1, comprising using a human serum albumin (HSA) solution having 。
26. In step (b), the washing is performed in the range of approximately 100 × g to approximately 1,000 × g. The method according to claim 1, comprising centrifugation of the sample using the centrifugal force of the surrounding area.
27. In step (b), the washing is performed on the sample for approximately 100 seconds to approximately 600 seconds. The method according to claim 1, comprising centrifugation.
28. In step (b), the washing process dilutes the sample by approximately 0 to approximately 5 times. The method according to claim 1, comprising the following:
29. In step (b), the cleaning includes performing the cleaning cycle 1 to 5 times. The method according to claim 1.
30. Step (b) has an output volume in the range of approximately 5 ml to approximately 400 ml, as described in claim 1. Method of loading.
31. In step (c), the selection is performed on anti-CD4 and / or anti-CD8 antibodies. The method according to claim 1, or the method comprising using a fragment thereof.
32. The sample is peripheral blood, immune cells, monocytes, or peripheral blood mononuclear cells (PBMCs). The method according to claim 1.
33. Genetically modified immune cells prepared by the method described in claim 1.
34. A cell preparation comprising the gene-modified immune cells described in claim 33.
35. A pharmaceutical composition comprising the gene-modified immune cells described in claim 33.