DK1545204T3 - Immunterapi med in vitro udvalgte antigenspecifikke lymfocytter efter non-myeloablativ lymphodepleterende kemoterapi - Google Patents
Immunterapi med in vitro udvalgte antigenspecifikke lymfocytter efter non-myeloablativ lymphodepleterende kemoterapi Download PDFInfo
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- DK1545204T3 DK1545204T3 DK03794636.5T DK03794636T DK1545204T3 DK 1545204 T3 DK1545204 T3 DK 1545204T3 DK 03794636 T DK03794636 T DK 03794636T DK 1545204 T3 DK1545204 T3 DK 1545204T3
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- A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
- A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterized by the route of administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
- A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the dose, timing or administration schedule
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
- A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
- A61K2239/57—Skin; melanoma
Claims (28)
1. Anvendelse af (A) et non-myeloablativt lymphodepleferende kemoterapeutisk middel, og (B1) autologe T-celler, som tidligere er blevet isoleret, udvalgt for højst aktiv genkendelse af et antigen i den cancer, hvis regressionen skal fremmes, og kun ekspanderet in vitro én gang, og (B2) en T-cellevækstfaktor, der fremmer væksten og aktivering af de autologe T-celler, i fremstillingen af et lægemiddel som fremmer regression af cancer i et pattedyr, hvori (b1) og (b2) er til indgivelse efter indgivelse af (a), og hvori (b2) skal indgives enten samtidig med (b1) eller efter (b1), af den samme vej eller en anden vej.
2. Anvendelse af (A) et non-myeloablativ lymphodepleferende kemoterapeutisk middel, og (B) autologe T-celler, som tidligere er blevet isoleret, udvalgt for højst aktiv genkendelse af et antigen i den cancer, hvis regressionen skal fremmes, modificeret til at udtrykke en T-cellevækstfaktor som fremmer væksten af aktiveringen af de autologe T-celler, og kun ekspanderet in vitro én gang, til fremstillingen af et medikament som fremmer regression af cancer i et pattedyr, hvori (b) skal indgives efter indgivelsen af (a).
3. Anvendelsen ifølge krav 1 eller 2, hvori T-cellevækstfaktoren er interleukin-2 (IL-2), interleukin-7 (IL-7), interleukin-15 (IL-15), eller en kombination af to eller af alle førnævnte.
4. Anvendelsen ifølge et hvilket som helst af kravene 1-3, hvori (a) omfatter cyclofosfamid og fludarabin, og hvori fortrinsvis omkring 60 mg / kg cyclofosfamid skal indgives i to dage, hvorefter omkring 25 mg / nr- fludarabin skal indgives i fem dage.
5. Anvendelsen ifølge krav 4, hvori cydofosfamld og fludarabin skal indgives intravenøst.
6. Anvendelsen ifølge et hvilket som helst af kravene 1,3, 4, eller 5, hvori en dosis på ca. 720.000 IE/ kg IL-2 skal indgives tre gange dagligt indtil tolerance, fortrinsvis som en bolusinjektion, hvorved fortrinsvis fra omkring 5 til omkring 12 doser af IL-2 og mere fortrinsvis omkring 9 doser af IL-2 skal indgives.
7. Anvendelsen ifølge et hvilket som helst af kravene 1-6, hvori fra omtrent 2,3 x 101G T-celler ti! omkring 13,7 x 101° T-celler, fortrinsvis omkring 7,8 x 101° T-celier, skal indgives, fortrinsvis som en intravenøs infusion, og hvori den intravenøse infusion varer fortrinsvis ca. 30-60 min.
8. Anvendelsen ifølge et hvilket som helst af kravene 1-7, hvori canceren er melanom.
9. Anvendelsen ifølge et hvilket som helst af kravene 1-8, hvori T-celler binder til melanom antigen, der genkendes af T-celler-1 (MART-1).
10. Anvendelsen ifølge et hvilket som helst af kravene 1-9, hvori canceren er metastatisk.
11. Anvendelsen ifølge et hvilket som helst af kravene 1-10, hvori pattedyret er et menneske.
12. Anvendelse af (A) cydofosfamld og fludarabin, og (Bl) autologe T-celler, som tidligere er blevet isoleret, udvalgt for højst aktiv genkendelse af MART-1, og kun ekspanderet in vitro én gang, og (B2) IL-2 i fremstillingen af et lægemiddel som fremmer regression af metastatisk melanom i et menneske, hvori omkring 60 mg / kg cyclofosfamid skal indgives intravenøst i to dage efterfulgt af intravenøs indgivelse af omkring 25 mg / m2 fludarabln i fem dage, og hvori omkring 2,3 x 1010 -13,7 X 10 ;0 autologe T-celler skal indgives som en infusion, og hvori en bolus på omkring720.0GG IE/ kg af IL-2 skal indgives tre gange dagligt indtil tolerance, hvorved bolus skal indgives enten samtidig med de autologe T-celler eller efter de autoioge T-celler, og hvori (b1) og (b2) skal indgives intravenøst efter indgivelse af (a).
13. Anvendelse af (A) cyclofosfamid og fludarabln, og (B) autologe T-celler, som tidligere er blevet isoleret, udvalgt for højst aktiv genkendelse af MART-1, modificeret til at udtrykke IL-2, og kun ekspanderet in vitro én gang, i fremstillingen af et medikament fil at fremme regression af metastatisk melanom i et menneske, hvori omkring 60 mg / kg cyclofosfamid skal indgives intravenøst i to dage efterfulgt af intravenøs indgivelse af omkring 25 mg / m2 fludarabln i fem dage, og hvori omkring 2,3 x 1G10 -13,7 X 1G10 autoioge T-ceiler skal indgives som en infusion, og hvori (b) er til intravenøs indgivelse efter indgivelse af (a).
14. Anvendelsen ifølge krav 12 eller 13, hvori omkring 7,8 x 1010 T-celler skal indgives.
15. Anvendelsen ifølge krav 12 eller 14, hvori fra omtrent 5 til omtrent 12 doser af IL-2, fortrinsvis omkring 9 doser af IL-2 skal indgives.
16. Anvendelsen ifølge et hvilket søm helst af kravene 12-15, hvor den intravenøse infusion varer ca. 30-60 min.
17. (a) Et non-myeioablativt lymphodepleterende kemoterapeutisk middel, og (b1) autoioge T-celler, som tidligere er bievet isoleret, udvalgt for højst aktiv genkendelse af et antigen i den cancer, hvis regressionen skal fremmes, ved stimulering af T-cellerne in vitro med antigenet i canceren og kun ekspanderet én gang ved yderligere stimulering af antigenet i canceren, og (B2) en T-celle vækstfaktor, der fremmer væksten og aktivering af de autologe T-celler, til anvendelse for at fremme regression af cancer i et pattedyr hvori (bl) og (b2) skal indgivelse efter indgivelse af (a), og hvor (b2) skal indgives enten samtidig med (bl) eller efter (b1), af den samme vej eller en anden vej.
18. (A) Et non-myeloablative lymphodepleterende kemoterapeutisk middel, og (B) autologe T-celler, som tidligere er blevet Isoleret, udvalgt for højst aktiv genkendelse af et antigen i den cancer, hvis regressionen skal fremmes, ved stimulering af T-cellerne in vitro med antigenet i canceren, modificeret til at udtrykke en T-cellevækstfaktor, der fremmer væksten og aktiveringen af autologe T-celler, og kun ekspanderet in vitro én gang ved yderligere stimulering af antigenet i canceren, til anvendelse for af fremme regression af cancer i et pattedyr, hvori (b) skal indgives efter indgivelse af (a).
19. Det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler og (b2) T-cellevækstfaktor eller det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel og (b) autologe T-celler ifølge krav 17 eller 18 til anvendelse ifølge krav 17 eller 18, hvori T-cellevækstfaktøren er IL-2, IL-7, IL-15 eller en kombination af to eller alle de foregående.
20. Del (a) non-myeioablative lymphodepleterende kemoterapeutisk middel (b1) autologe T-celler, og (fa2) T-celle vækstfaktor eller det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel og (b) autologe T~celler ifølge et hvilket som helst af kravene 17-19 til anvendelse ifølge krav 17-19, hvori (a) omfatter cyclofosfamid of fluderabin og hvori fortrinsvis omkring 80 mg/kg cyclofosfamid skal indgives i to dage hvorefter omkring 25/ mg/m2 fluderabin skal indgives i 5 dage.
21. Det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel og (b) autologe T-celler ifølge krav 20 til anvendelse ifølge krav 20, hvori cyclofosfamid og fludarabin skal indgives intravenøst.
22. Det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge et hvilket som helst af kravene 17, 19, 20 og 21 til anvendelse ifølge et hvilket som helst af af kravene 17, 19, 20 og 21, hvori en dosis på ca. 720.000 IE / kg IL-2 skal indgives tre gange dagligt indtil tolerance, fortrinsvis som en bolus intravenøs injektion, hvorved fortrinsvis fra omtrent 5 fil omtrent 12 doser af IL-2 skal indgives, og mere fortrinsvis omkring 9 doser af IL-2 skal indgives.
23. Det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative lymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge et hvilket som helst af kravene 17- 22 til anvendelse ifølge et hvilket som helst af kravene 17-22, hvori fra omtrent 1,2 x 1010 T-celler til omtrent 4,3 x 1010 T-celler skal indgives, hvori T-cellerne fortrinsvis indgives som en intravenøs infusion, og hvori den intravenøs infusion fortrinsvis varer ca. 30-80 min.
24. Det (a) non-myeioabiative iymphodepleterende kemoterapeutisk middel, (b1) autoioge T-celler, og (b2) T-cellevækstfaktor eller det fa) non-myeioabiative Iymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge et hvilket som helst af kravene 17- 23 til anvendelsen ifølge et hvilket som helst af kravene 17-23, hvori canceren er melanom.
25. Det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge krav 24 til anvendelse ifølge krav 24, hvori T-cellerne binder til MART-1.
26. Det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge et hvilket som helst af kravene 17- 25 til anvendelse ifølge et hvilket som helst af kravene 17-25, hvori canceren er metastatisk.
27. Det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, og (b) autoioge T-celler ifølge et hvilket som helst af kravene 17- 26 til anvendelse ifølge et hvilket som helst af kravene 17-28, hvori pattedyret er et menneske.
28 Det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, (b1) autologe T-celler, og (b2) T-cellevækstfaktor eller det (a) non-myeloablative Iymphodepleterende kemoterapeutisk middel, og (b) autologe T-celler ifølge et hvilket som helst af kravene 17- 27 til anvendelse ifølge et hvilket som helst af kravene 17-27, hvori cancerens antigen består af aminosyrer 28-35 af MART-1, hvori aminosyre 27 er blevet erstattet med leucin, og / eller cancerens antigen består af aminosyrer 209-217 af gp100, hvori aminosyre 210 er blevet erstattet med methionin.
Applications Claiming Priority (2)
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| US40868102P | 2002-09-06 | 2002-09-06 | |
| PCT/US2003/027873 WO2004021995A2 (en) | 2002-09-06 | 2003-09-05 | Immunotherapy with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy |
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| DK1545204T3 true DK1545204T3 (da) | 2016-11-14 |
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| DK03794636.5T DK1545204T3 (da) | 2002-09-06 | 2003-09-05 | Immunterapi med in vitro udvalgte antigenspecifikke lymfocytter efter non-myeloablativ lymphodepleterende kemoterapi |
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