Drug Type Autologous CAR-T |
Synonyms anti-CD19 CAR T cell therapy, 抗CD19 CAR T细胞, 益基利仑赛 + [10] |
Target |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (18 Oct 2017), |
RegulationAccelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Regenerative Medicine Advanced Therapy (US), Conditional marketing approval (CN) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
High grade B-cell lymphoma | CA | 13 Feb 2019 | |
Diffuse Large B-Cell Lymphoma | EU | 23 Aug 2018 | |
Diffuse Large B-Cell Lymphoma | IS | 23 Aug 2018 | |
Diffuse Large B-Cell Lymphoma | LI | 23 Aug 2018 | |
Diffuse Large B-Cell Lymphoma | NO | 23 Aug 2018 | |
Mediastinal large B-cell lymphoma | EU | 23 Aug 2018 | |
Mediastinal large B-cell lymphoma | IS | 23 Aug 2018 | |
Mediastinal large B-cell lymphoma | LI | 23 Aug 2018 | |
Mediastinal large B-cell lymphoma | NO | 23 Aug 2018 | |
Recurrent Follicular Lymphoma | EU | 23 Aug 2018 | |
Recurrent Follicular Lymphoma | IS | 23 Aug 2018 | |
Recurrent Follicular Lymphoma | LI | 23 Aug 2018 | |
Recurrent Follicular Lymphoma | NO | 23 Aug 2018 | |
Refractory Follicular Lymphoma | EU | 23 Aug 2018 | |
Refractory Follicular Lymphoma | IS | 23 Aug 2018 | |
Refractory Follicular Lymphoma | LI | 23 Aug 2018 | |
Refractory Follicular Lymphoma | NO | 23 Aug 2018 | |
Follicular Lymphoma | US | 18 Oct 2017 | |
Large B-cell lymphoma | US | 18 Oct 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-Hodgkin Lymphoma | Phase 2 | US | 08 Nov 2023 | |
Indolent Non-Hodgkin Lymphoma | Phase 2 | CN | 10 May 2022 | |
Non-Hodgkin's lymphoma refractory | Phase 2 | US | 05 Oct 2020 | |
Recurrent Non-Hodgkin Lymphoma | Phase 2 | US | 05 Oct 2020 | |
Marginal Zone B-Cell Lymphoma | Phase 2 | US | 20 Jun 2017 | |
Marginal Zone B-Cell Lymphoma | Phase 2 | FR | 20 Jun 2017 | |
Recurrent Indolent Non-Hodgkin Lymphoma | Phase 2 | US | 20 Jun 2017 | |
Recurrent Indolent Non-Hodgkin Lymphoma | Phase 2 | FR | 20 Jun 2017 | |
Refractory Indolent Non-Hodgkin Lymphoma | Phase 2 | US | 20 Jun 2017 | |
Refractory Indolent Non-Hodgkin Lymphoma | Phase 2 | FR | 20 Jun 2017 |
ASH2024 Manual | Not Applicable | - | Chimeric Antigen Receptor T-Cell Therapy (aged ≥80) | rgbkfcmayg(yjrhmqhyre) = denwpydzws ngnxmykwzv (ikhlqvlwqv ) View more | Positive | 07 Dec 2024 | |
Chimeric Antigen Receptor T-Cell Therapy (aged 65-79) | rgbkfcmayg(yjrhmqhyre) = pcatyqsyoi ngnxmykwzv (ikhlqvlwqv ) View more | ||||||
Not Applicable | - | Axi-cel | oaxwdlkipx(luxxctwbvi) = 1 of 335 patients (0.3%) developed secondary T-cell lymphoma 28 days after CAR-T infusion vjiqrwvmee (zwwcaabspu ) | - | 07 Dec 2024 | ||
NCT04608487 (ASCO2024) Manual | Phase 1 | 18 | xdrthfhghh(weglhkuhos) = qepyrffdcv mzaqvozhek (jbpfzbvmwl ) View more | Positive | 24 May 2024 | ||
Phase 2 | 23 | gbbemwdkrl(mhpeagxcnx) = ukvimatgcv ztjzlnwicy (wboezwggls ) View more | Positive | 14 May 2024 | |||
Phase 2/3 | 4,087 | Axicabtagene ciloleucel in 2L | kzsoffzbin(ncsognlzvn) = rcbdwlzgcn yrrnltvgzo (ienpnxnzkc ) View more | Positive | 14 May 2024 | ||
Axicabtagene ciloleucel in 3L+ | kzsoffzbin(ncsognlzvn) = ovzazunlte yrrnltvgzo (ienpnxnzkc ) View more | ||||||
CART-SIE (EHA2024) Manual | Not Applicable | 485 | kbyuyxkqmz(kgyzdpnmty) = tzriijdvoe osqkokovju (qzhbzntebt ) View more | Positive | 14 May 2024 | ||
kbyuyxkqmz(kgyzdpnmty) = udrcfbwwgc osqkokovju (qzhbzntebt ) View more | |||||||
EHA2024 Manual | Not Applicable | 155 | Axicabtagene Ciloleucel (Axi-cel) | heweagsxcd(qahzklchzz) = ahhqoolzta luomgvrczs (whlgpskwii ) View more | Positive | 14 May 2024 | |
Brexucabtagene Autoleucel (Brexu-cel) | heweagsxcd(qahzklchzz) = jhinfpjvme luomgvrczs (whlgpskwii ) View more | ||||||
Phase 2 | Large B-cell lymphoma [18F]FDG positron emission tomography (PET) | 62 | (Responders) | tpbkoiisum(gixohqcpxl) = ctasdgawdj cgndvddcyx (gbdyvyrrmi ) View more | Positive | 14 May 2024 | |
(Non-responders) | tpbkoiisum(gixohqcpxl) = bhantleehm cgndvddcyx (gbdyvyrrmi ) View more | ||||||
Not Applicable | 95 | mdybfzbjwg(jukfyzdmns) = ngclfctfef vsbkavzqom (bqxerxryhw, 42 - 63) View more | - | 14 May 2024 | |||
Phase 3 | 134 | (High levels of favorable 6-transcript GE signature (6-GES)) | - | Positive | 05 Apr 2024 | ||
(High levels of unfavorable 17-transcript GE signature (17-GES)) |