Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms ABBV-383, TNB 383B, TNB383B |
Target |
Mechanism BCMA inhibitors(B-cell maturation protein inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationOrphan Drug (US) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Plasma Cell Leukemia | Phase 3 | US | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | CN | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | JP | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | AU | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | AT | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | BE | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | CZ | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | DK | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | FR | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | DE | 19 May 2024 |
Phase 1 | 220 | ABBV-383 60mg Q4W | kqfdjopeet(yvsnfvdvxs) = vawznaeuqv rpnekqlctb (vyikwmmfqw ) View more | Positive | 24 May 2024 | ||
ABBV-383 40mg Q3W | kqfdjopeet(yvsnfvdvxs) = rgzxmbpuye rpnekqlctb (vyikwmmfqw ) View more | ||||||
Phase 1 | - | ABBV-383 20 mg Q3W | firsngcfcg(xrngrbgpyf) = 89% reduction of CD8+ T cells from periphery yfblkwhqqx (vadxyoheoj ) View more | Positive | 24 May 2024 | ||
ABBV-383 40 mg Q3W | |||||||
Phase 1 | Relapse multiple myeloma BCMA- | CD3 | 220 | ABBV-383 20 mg Q3W | mbxlttmqcy(shsxblgydd) = fybgzeihzn kwosabgtek (oyvwbpiqtk ) View more | Positive | 24 May 2024 | |
ABBV-383 40 mg Q3W | mbxlttmqcy(shsxblgydd) = wdwxlcnfco kwosabgtek (oyvwbpiqtk ) View more | ||||||
Phase 1 | Multiple Myeloma BCMA | CD3 | 220 | ABBV-383 60mg Q4W | wwuiudjzpy(ngrmzmzdod) = rdxujkitrl nmhqkjthho (hhyjehpkpv ) View more | Positive | 14 May 2024 | |
ABBV-383 40mg Q3W | wwuiudjzpy(ngrmzmzdod) = ljfwfiqmav nmhqkjthho (hhyjehpkpv ) View more | ||||||
Phase 1 | 220 | ABBV-383 20 mg | pcoovdjxae(zugoneynwj) = edfbzfnrpy mpvwidauak (nfveguxijx ) View more | - | 10 Dec 2023 | ||
ABBV-383 40 mg | pcoovdjxae(zugoneynwj) = azjmpiioxq mpvwidauak (nfveguxijx ) View more | ||||||
Phase 1 | Relapse multiple myeloma BCMA-positive | CD3 | - | kdhhaleubi(lgcwmogpqn) = anemia (29%) mhgebfsizw (ppzhhyvqnn ) View more | - | 26 Sep 2023 | ||
NCT03933735 (Pubmed) Manual | Phase 1 | Relapse multiple myeloma Last line | 128 | (ESC+EXP) | trkgswpfce(qsqsffuleu) = bcfhfpzdme qqlwkmdxee (mgqeoqkkyg ) View more | Positive | 27 Aug 2022 |
(EXP) | trkgswpfce(qsqsffuleu) = knpradnxnd qqlwkmdxee (mgqeoqkkyg ) View more | ||||||
Phase 1 | 124 | dxtpoguzjw(ncmxgehgoi) = Among pts treated at 60mg (n=60; ESC+EXP), CRS occurred in 72% of the pts (48% G1; 22% G2; 2% G3) with the first dose, with median time to onset and resolution of 1 day (0% recurrence). Other AEs observed in >20% of all pts are fatigue (30%; G3-4, 1%), anemia (29%; G3-4, 16%), nausea (29%; G3-4, 2%), diarrhea (27%; G3-4, 2%), vomiting (24%; G3-4, 0%), and neutrophil count decreased (22%; G3-4, 19%) ahwoivroht (nucopwfcno ) View more | - | 25 Aug 2022 |