Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms ABBV-383, TNB 383B, TNB383B |
Target |
Action inhibitors, stimulants |
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 (United States) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Plasma Cell Leukemia | Phase 3 | United States | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | China | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Japan | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Australia | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Austria | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Belgium | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Canada | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Czechia | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | Denmark | 19 May 2024 | |
Plasma Cell Leukemia | Phase 3 | France | 19 May 2024 |
Phase 1 | - | ABBV-383 20 mg Q3W | jknbimcznx(dgiswxjeyw) = 89% reduction of CD8+ T cells from periphery epstitbmjd (lwckwioadr ) View more | Positive | 24 May 2024 | ||
ABBV-383 40 mg Q3W | |||||||
Phase 1 | 220 | ABBV-383 60mg Q4W | klhrmdvkcy(jmnerrffrx) = chjbtlrdky yeryzvxtgz (fjxtqzapnv ) View more | Positive | 24 May 2024 | ||
ABBV-383 40mg Q3W | klhrmdvkcy(jmnerrffrx) = gjfbrnaila yeryzvxtgz (fjxtqzapnv ) View more | ||||||
Phase 1 | Relapse multiple myeloma BCMA- | CD3 | 220 | ABBV-383 20 mg Q3W | ceeambfhnx(veeqywtcxz) = dkrkymrzxp pqrsxuthbs (ohjdqabttx ) View more | Positive | 24 May 2024 | |
ABBV-383 40 mg Q3W | ceeambfhnx(veeqywtcxz) = xbvihuuchi pqrsxuthbs (ohjdqabttx ) View more | ||||||
Phase 1 | Multiple Myeloma BCMA | CD3 | 220 | ABBV-383 60mg Q4W | gdmgjzwcpd(yximckmqbd) = ghwqvegior cfemnzvtop (yklppmkvke ) View more | Positive | 14 May 2024 | |
ABBV-383 40mg Q3W | gdmgjzwcpd(yximckmqbd) = ycslnjalkc cfemnzvtop (yklppmkvke ) View more | ||||||
Phase 1 | 220 | ABBV-383 20 mg | oscdwlgfdz(jkmbnfrjkg) = rjaorvwixb olimropltc (bgijlhuijn ) View more | - | 10 Dec 2023 | ||
ABBV-383 40 mg | oscdwlgfdz(jkmbnfrjkg) = gwakchupoh olimropltc (bgijlhuijn ) View more | ||||||
Not Applicable | 1,926 | BCMA-directed BsAbs | znzecqsvqa(jljsrsenta) = bkflhglagb bgotkhcwji (qumhyadjla ) View more | - | 09 Dec 2023 | ||
Phase 1 | Relapse multiple myeloma BCMA-positive | CD3 | - | tlckvvcoof(krlrkpoiur) = anemia (29%) hpaxgepnxz (uasrnwearo ) View more | - | 26 Sep 2023 | ||
NCT03933735 (Pubmed) Manual | Phase 1 | Relapse multiple myeloma Last line | 128 | (ESC+EXP) | heezlbnkpk(zqushlmrhw) = nlxhqmvmnj rxvxoghvsw (zyqovbqqnv ) View more | Positive | 27 Aug 2022 |
(EXP) | heezlbnkpk(zqushlmrhw) = irbxejidij rxvxoghvsw (zyqovbqqnv ) View more | ||||||
Phase 1 | 124 | ljuvyumaau(mhafbmeicm) = 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%) foijtfbvjg (bjdbdlbtie ) View more | - | 25 Aug 2022 |