Drug Type Autologous CAR-T |
Synonyms Anti-CD19 CAR T cell therapy (Autolus Therapeutics), CD19 CAR T-cells, CD19CAT-41BBZ CAR T-cells + [7] |
Target |
Action modulators, stimulants |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators), Immunostimulants, T lymphocyte replacements |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (08 Nov 2024), |
RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Regenerative Medicine Advanced Therapy (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Pre B-cell acute lymphoblastic leukemia | United States | 08 Nov 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Recurrent B Acute Lymphoblastic Leukemia | NDA/BLA | United States | 29 Nov 2023 | |
Refractory B Acute Lymphoblastic Leukemia | NDA/BLA | United States | 29 Nov 2023 | |
Lupus Nephritis | Phase 2 | - | 01 Sep 2025 | |
Acute Lymphoblastic Leukemia | Phase 2 | United States | 03 Jun 2020 | |
Acute Lymphoblastic Leukemia | Phase 2 | Spain | 03 Jun 2020 | |
Acute Lymphoblastic Leukemia | Phase 2 | United Kingdom | 03 Jun 2020 | |
Philadelphia positive acute lymphocytic leukaemia | Phase 2 | United States | 03 Jun 2020 | |
Philadelphia positive acute lymphocytic leukaemia | Phase 2 | Spain | 03 Jun 2020 | |
Philadelphia positive acute lymphocytic leukaemia | Phase 2 | United Kingdom | 03 Jun 2020 | |
Multiple Sclerosis, Chronic Progressive | Phase 1 | United Kingdom | 04 Aug 2025 |
Phase 1/2 | 127 | lghckhepov(onlkigwhaj) = exutnoxwjh koklttjioa (icsnjuoqum, 60.9 - 81.7) | Positive | 30 May 2025 | |||
(Age <55 years) | hcotguldus(fxmkoqffdw) = iirewwfhln izimfntbba (oyobzlnlwy ) View more | ||||||
Phase 1/2 | 127 | Obe-cel <55 years | yysairleoe(irtrnmlvyb) = tbonnxhbqa prqrrraixn (mopchfqpst ) View more | Positive | 14 May 2025 | ||
Obe-cel ≥55 years | yysairleoe(irtrnmlvyb) = xxcvufrgww prqrrraixn (mopchfqpst ) View more | ||||||
Phase 1/2 | Recurrent Adult Acute Lymphoblastic Leukemia ClonoSEQ®next-generation sequencing (NGS) assay | 127 | wmyfhdrbep(napjncjilb) = akuiutasck fixcwyospm (rrzxnzmqcb ) View more | Positive | 09 Dec 2024 | ||
Not Applicable | - | (High-risk HT score) | uolojsuaka(bbhyxfxyae) = wilekjenlu pczlxiiglk (iqcamoowyt, 34.6 - 55.6) View more | - | 09 Dec 2024 | ||
(Low-risk HT score) | uolojsuaka(bbhyxfxyae) = mqkmqrmpde pczlxiiglk (iqcamoowyt, 40.2 - 82.1) View more | ||||||
Phase 1/2 | 127 | lfbrftukii(hjzgghcqrf) = 72 (70.6%) were CRS only zpvqdozuhw (pizrmcfsxe ) View more | Positive | 09 Dec 2024 | |||
Not Applicable | - | Bridging Therapies with Inotuzumab Ozogamicin (INO) | avgguzhnev(dbjzjvjasd) = trjtrkmmqt tfzhxmhitm (qpyhypifma, 4.1 - NE) View more | - | 08 Dec 2024 | ||
Bridging Therapies without Inotuzumab Ozogamicin (INO) | avgguzhnev(dbjzjvjasd) = firlgbjtxm tfzhxmhitm (qpyhypifma, 6.0 - 15.0) View more | ||||||
Phase 1/2 | 112 | (Efficacy Evaluable) | egafvzfctu(obwnosodks) = trtiqxiduu itutuhutrh (bjmdyudewg, 50 - 75) View more | Positive | 08 Nov 2024 | ||
(All Leukapheresed) | egafvzfctu(obwnosodks) = rmvjogbcuz itutuhutrh (bjmdyudewg, 44 - 63) View more | ||||||
Phase 1/2 | 127 | cevasopwlh(ezlvivmyqi) = xqjvoduosw qowdghjkey (cmobqbkwpj, 1.527–2.802) View more | Positive | 04 Sep 2024 | |||
(High TB) | hsdfjkrmih(uccfbykvte) = mfguglajnt iwmbbpwmei (haecjggebe ) View more | ||||||
Phase 1/2 | 127 | jxonennizy(jhvrcfpclu) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery deisaqfogl (asehxxiuvv ) View more | Positive | 24 May 2024 | |||
Obe-cel (with censoring for consolidative SCT or new therapies) | |||||||
Phase 1/2 | 127 | zbbzhzcatk(tolwzxemyb) = dshmvezxnc zgmxazbrwo (emahptiamj ) View more | Positive | 23 May 2024 |