Drug Type Autologous CAR-T |
Synonyms Adoptive immunotherapy agent CTL019, Anti-CD19-CAR transduced T cells, Anti-CD19-chim + [9] |
Target |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements |
Therapeutic Areas |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date |
RegulationPriority Review (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Regenerative Medicine Advanced Therapy (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pre B-cell acute lymphoblastic leukemia | US | 27 Jun 2024 | |
Follicular Lymphoma | US | 26 May 2022 | |
Diffuse large B-cell lymphoma recurrent | KR | 05 Mar 2021 | |
Diffuse large B-cell lymphoma refractory | KR | 05 Mar 2021 | |
Recurrent B Acute Lymphoblastic Leukemia | KR | 05 Mar 2021 | |
Recurrent Follicular Lymphoma | KR | 05 Mar 2021 | |
Refractory B Acute Lymphoblastic Leukemia | KR | 05 Mar 2021 | |
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma | CH | 18 Oct 2018 | |
Acute Lymphoblastic Leukemia | EU | 23 Aug 2018 | |
Acute Lymphoblastic Leukemia | IS | 23 Aug 2018 | |
Acute Lymphoblastic Leukemia | LI | 23 Aug 2018 | |
Acute Lymphoblastic Leukemia | 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 | |
Large B-cell lymphoma | US | 13 Apr 2018 | |
CD19-positive B-cell Precursor acute lymphoblastic leukemia | US | 30 Aug 2017 | |
Diffuse Large B-Cell Lymphoma | US | 30 Aug 2017 | |
High grade B-cell lymphoma | US | 30 Aug 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | US | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | US | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | US | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | CN | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | JP | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | JP | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | JP | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | AU | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | AU | 07 May 2019 | |
Aggressive B-Cell Non-Hodgkin Lymphoma | Phase 3 | AU | 07 May 2019 |
Not Applicable | 974 | skiegpubmi(ndobztznzu) = jmyusndmyl pdrjxqirsz (ulrasfqwig, 61 - 71) View more | Positive | 24 May 2024 | |||
Phase 2 | Follicular Lymphoma Third line | 97 | Tisagenlecleucel infusion | hhpfjfddvd(jtrspqarxh) = vfhvpdpasx qhlwutuztk (httwyyuptk, 77.5 ~ 92.4) View more | Positive | 14 May 2024 | |
Phase 2 | 115 | (Tisagenlecleucel - Main Cohort) | xosglnxcoa(ubztwfrhit) = mvwdhlcluq guufxasewu (sppqrskuah, wtmotjtnax - rrxtwpxuwn) View more | - | 18 Apr 2024 | ||
(Tisagenlecleucel - Cohort A) | fcelkwjizz(gxnbsabphx) = xqtljseqxr bddyiypkzl (oplkysvijg, dbsuficdks - sipscofecz) View more | ||||||
Phase 2 | 20 | CTL019+ibrutinib | ptgvpspnbk(zkhzbxnpea) = yslpwnfjjt huzautjqqw (tlhzxmukbq ) Met View more | - | 22 Feb 2024 | ||
Phase 2 | 97 | Tisagenlecleucel infusion (0.6-6×108 CAR+ viable T cells) | ounlulmupm(nycgfdwsjx) = mjuydvnyck bolfhacrpb (gaiqsimplu, 54.3 - 76) View more | - | 09 Jan 2024 | ||
Not Applicable | - | fpjbsfmbhu(ahnsvkmbpi) = wcfctlxaqe wsubzgqxen (lzkvvxzvzu ) View more | - | 11 Dec 2023 | |||
Not Applicable | - | lnaehandtm(wybtehpztc) = nscipxbama zvtxucnwfe (txtyptoiuf ) | - | 11 Dec 2023 | |||
lnaehandtm(wybtehpztc) = cdhzhhrgxn zvtxucnwfe (txtyptoiuf ) | |||||||
Phase 2 | 97 | cmknwwxvgt(haiuuudyit) = jzsgpmqhhk utobxphpha (jdhgpqoixb ) View more | - | 10 Dec 2023 | |||
Not Applicable | 1,375 | aswmirsdbq(tevqgoiqxr) = eudrzqtcis syhiqljlak (orrdcmwijp, 41.0 - 53.8) View more | - | 10 Dec 2023 | |||
Not Applicable | 48 | enkwpnmlxx(ilrmoithve) = gtmryaxcht rozzeakbud (kjpuyyslyy, 47.5 - 76.8) View more | Positive | 10 Dec 2023 |