Drug Type Autologous CAR-T |
Synonyms Autologous anti-CD19 CAR T cell immunotherapy transduced with lentiviral vector (Kyverna), KYV 101, KYV101 |
Target |
Action inhibitors, agonists |
Mechanism CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD28 agonists(T-cell-specific surface glycoprotein CD28 agonists), T lymphocyte replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 2/3 |
First Approval Date- |
RegulationFast Track (United States), Orphan Drug (United States), Regenerative Medicine Advanced Therapy (United States) |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Myasthenia Gravis | Phase 3 | United States | 28 Aug 2024 | |
| Myasthenia Gravis | Phase 3 | Brazil | 28 Aug 2024 | |
| Myasthenia Gravis | Phase 3 | Germany | 28 Aug 2024 | |
| Granulomatosis With Polyangiitis | Phase 2 | - | 01 Jan 2025 | |
| Microscopic Polyangiitis | Phase 2 | - | 01 Jan 2025 | |
| Rheumatoid Arthritis | Phase 2 | - | 01 Nov 2024 | |
| Ischiopatellar Dysplasia | Phase 2 | United States | 25 Sep 2024 | |
| Stiff-Person Syndrome | Phase 2 | United States | 25 Sep 2024 | |
| Multiple Sclerosis, Primary Progressive | Phase 2 | United States | 20 Sep 2024 | |
| Multiple Sclerosis, Secondary Progressive | Phase 2 | United States | 20 Sep 2024 |
Phase 2/3 | 6 | nphiklnjgh(nyvgkmeaum) = sriihdvlvm qoirwghdoo (twxzikcmwr ) View more | Positive | 29 Oct 2025 | |||
Phase 1/2 | 6 | hassdhfurj(lcmmacstvy) = No High-Grade CRS or ICANS Observed. lvstpnitap (ljdscgurfj ) View more | Positive | 14 Nov 2024 | |||
Company_Website Manual | Not Applicable | 41 | ptaksohbtk(itoltewhpi) = In stiff-person syndrome, two patients treated with KYV-101 have demonstrated improved mobility and/or walking speed and reduced autoantibody titers, including one patient at greater than one year post-infusion. A third patient demonstrated reduced autoantibody titers but does not yet have mobility scores available. In myasthenia gravis, three patients treated with KYV-101 have shown reduced pathogenic anti-AChR antibody titers and sustained disease control, including two patients at more than one year post-infusion and all three at greater than 8 months post-infusion. In multiple sclerosis, five patients treated with KYV-101 who failed prior anti-CD20 medications have shown a significant and unprecedented average reduction in oligoclonal bands in the central nervous system (CNS), a potential surrogate biomarker for reduced disease progression. ypwcmavbxm (zekskscnby ) View more | Positive | 18 Sep 2024 | ||
PRNewswire Manual | Not Applicable | 1 | mlwyfydtkl(uggydofnfv) = jrugusvbsj grvrkdahik (kpvzxojtkr ) | Positive | 17 Jun 2024 | ||
Not Applicable | 50 | icmmmowpqd(ygxxtnzfpb) = ifkczgjmid wpkfkibjok (mtzexfkpnn ) | Positive | 14 Jun 2024 | |||
PRNewswire Manual | Not Applicable | 1 | voddavtolq(kbwwojhexy) = sixgojwjlc xxrkkdxwct (gdzcscfzkk ) View more | Positive | 15 Nov 2023 | ||
Phase 1 | 27 | (LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only) | sfgjeetjrt = cxeroxfqes omlqgwtafr (cizbnitcuq, kvvfuqjmza - ewbubrigoh) View more | - | 04 May 2021 | ||
Fludarabine+Cyclophosphamide+Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells) | sfgjeetjrt = suqswtmbcs omlqgwtafr (cizbnitcuq, gaeuuujici - ewgwlhffiw) View more |





