- Document Number:
20250017967
- Appl. No:
18/711861
- Application Filed:
December 16, 2022
- نبذة مختصرة :
The present invention relates to the field of adoptive cell therapy (ACT), particularly to a method for conditioning a subject for treatment with a medicament comprising regulatory T cells (Tregs), the method comprising administering a low dose of anti-thymocyte globulin (ATG) to the subject about 8 weeks or less before administration of the medicament.
- Claim:
1. A method for conditioning a subject for treatment with a medicament comprising regulatory T cells (Tregs), the method comprising administering a low dose of anti-thymocyte globulin (ATG) to the subject about 8 weeks or less before administration of the medicament.
- Claim:
2. A method of immunomodulation of a subject in need thereof comprising the steps of: (a) administering a low dose of anti-thymocyte globulin (ATG) to the subject; and (b) administering a medicament comprising regulatory T cells (Tregs) to the subject, wherein step (a) occurs about 8 weeks or less before step (b).
- Claim:
3. The method of claim 1 or 2, wherein the Tregs are chimeric antigen receptor (CAR)-Tregs.
- Claim:
4. The method of any one of claims 1 to 3, wherein the low dose of ATG is administered in a single dose.
- Claim:
5. The method of any one of claims 1 to 4, wherein the subject does not receive any further doses of ATG after administration of the medicament.
- Claim:
6. The method of any one of claims 1 to 5, wherein the subject is administered a single dose of the medicament.
- Claim:
7. The method of any one of claims 1 to 6, further comprising a step of performing leukapheresis on the subject to isolate T cells for use in the preparation of the medicament before the step of administering the low dose of ATG.
- Claim:
8. The method of any one of claims 1 to 7, wherein the ATG is rabbit ATG.
- Claim:
9. The method of any one of claims 1 to 8, wherein the low dose of ATG is about 3 mg/kg or less.
- Claim:
10. The method of any one of claims 1 to 9, wherein the subject is on an immunosuppressive drug therapy comprising a calcineurin inhibitor (CNI), optionally wherein the CNI is tacrolimus.
- Claim:
11. The method of claim 10, wherein the immunosuppressive drug therapy is a combination therapy consisting of a CNI and an mTOR inhibitor, optionally wherein the immunosuppressive drug therapy is a combination therapy consisting of tacrolimus and everolimus.
- Claim:
12. The method of claim 10 or 11, wherein when the subject is on an immunosuppressive drug therapy other than a combination therapy consisting of tacrolimus and everolimus, the method comprises a step of switching the immunosuppressive drug therapy to a combination therapy consisting of tacrolimus and everolimus.
- Claim:
13. The method of claim 12, wherein the step of switching the immunosuppressive drug therapy to a combination therapy consisting of tacrolimus and everolimus is complete before the step of administering the low dose of ATG, preferably at least about 6 weeks before the step of administering the low dose of ATG.
- Claim:
14. The method of claim 12 or 13, wherein the step of switching the immunosuppressive drug therapy to a combination therapy consisting of tacrolimus and everolimus is complete before leukapheresis is performed on the subject to isolate T cells for use in the preparation of the medicament, preferably at least about 2 weeks before leukapheresis is performed on the subject.
- Claim:
15. The method of any one of claims 10 to 14, wherein the method comprises stopping administration of tacrolimus about 2-4 weeks after the step of administering the low dose of ATG and/or about 5-10 days before administration of the medicament.
- Claim:
16. The method of any one of claims 12 to 15 further comprising a step of weaning the subject off everolimus, optionally wherein weaning is started at least about 4 weeks after administration of the medicament.
- Claim:
17. The method of any one of claims 1 to 16, wherein the subject has an inflammatory or autoimmune disease or condition.
- Claim:
18. The method of any one of claims 2 to 17, wherein the method of immunomodulation is for treating an inflammatory or autoimmune disease or condition.
- Claim:
19. The method of claim 17 or 18, wherein the inflammatory or autoimmune disease or condition is type I diabetes or inflammatory bowel disease.
- Claim:
20. The method of any one of claims 1 to 19, wherein the subject is a transplant recipient.
- Claim:
21. The method of any one of claims 2 to 20, wherein the method of immunomodulation is for treating and/or preventing rejection of a transplant.
- Claim:
22. The method of any one of claims 2 to 20, wherein the method of immunomodulation is for inducing functional immune tolerance in a transplant recipient.
- Claim:
23. The method of any one of claims 20 to 22, wherein the transplant is a solid organ or part thereof or a graft.
- Claim:
24. The method of claim 23, wherein the solid organ is a liver, kidney, heart, lung, pancreas, intestine or stomach or a part thereof, optionally a portion of a liver, a heart valve or a lung lobe.
- Claim:
25. The method of claim 23, wherein the graft is a cell or tissue transplant, optionally wherein the tissue a vascularized composite tissue, skin, a cornea, a blood vessel, a muscle, a heart valve or a bone and/or the cells are islet of Langerhans cells, bone marrow or adult stem cells.
- Claim:
26. A low dose of anti-thymocyte globulin (ATG) for use in conditioning a subject for treatment with a medicament comprising regulatory T cells (Tregs), wherein said ATG is for administration about 8 weeks or less before administration of the medicament.
- Claim:
27. A low dose of anti-thymocyte globulin (ATG) for use in immunomodulation of a subject in need thereof, wherein said immunomodulation comprises administration of a medicament comprising regulatory T cells (Tregs) to the subject and wherein said low dose of ATG is for administration about 8 weeks or less before administration of said medicament.
- Claim:
28. A combination therapy or product comprising a low dose of anti-thymocyte globulin (ATG) and a medicament comprising regulatory T cells (Tregs), wherein the components of the combination therapy or product are for separate and sequential use in immunomodulation of a subject, wherein said ATG is for administration about 8 weeks or less before administration of the medicament.
- Claim:
29. A kit comprising: (i) anti-thymocyte globulin (ATG); and (ii) a medicament comprising regulatory T cells (Tregs), for separate and sequential use in the immunomodulation of a subject, wherein said ATG is for administration at a low dose about 8 weeks or less before administration of the medicament.
- Claim:
30. A low dose of anti-thymocyte globulin (ATG) for use of claim 26 or 27, a combined therapy or product for use of claim 28 or a kit for use of claim 29, wherein the ATG, medicament, subject or immunomodulation is as defined in any one of claims 3 to 25.
- Current International Class:
61; 61; 07
- الرقم المعرف:
edspap.20250017967
Processing Request
No Comments.