Last update 25 Aug 2025

Obecabatagene autoleucel

Overview

Basic Info

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
Originator Organization
Inactive 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)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pre B-cell acute lymphoblastic leukemia
United States
08 Nov 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent B Acute Lymphoblastic LeukemiaNDA/BLA
United States
29 Nov 2023
Refractory B Acute Lymphoblastic LeukemiaNDA/BLA
United States
29 Nov 2023
Lupus NephritisPhase 2-01 Sep 2025
Acute Lymphoblastic LeukemiaPhase 2
United States
03 Jun 2020
Acute Lymphoblastic LeukemiaPhase 2
Spain
03 Jun 2020
Acute Lymphoblastic LeukemiaPhase 2
United Kingdom
03 Jun 2020
Philadelphia positive acute lymphocytic leukaemiaPhase 2
United States
03 Jun 2020
Philadelphia positive acute lymphocytic leukaemiaPhase 2
Spain
03 Jun 2020
Philadelphia positive acute lymphocytic leukaemiaPhase 2
United Kingdom
03 Jun 2020
Multiple Sclerosis, Chronic ProgressivePhase 1
United Kingdom
04 Aug 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
127
lghckhepov(onlkigwhaj) = exutnoxwjh koklttjioa (icsnjuoqum, 60.9 - 81.7)
Positive
30 May 2025
hcotguldus(fxmkoqffdw) = iirewwfhln izimfntbba (oyobzlnlwy )
Phase 1/2
127
Obe-cel <55 years
yysairleoe(irtrnmlvyb) = tbonnxhbqa prqrrraixn (mopchfqpst )
Positive
14 May 2025
Obe-cel ≥55 years
yysairleoe(irtrnmlvyb) = xxcvufrgww prqrrraixn (mopchfqpst )
Phase 1/2
Recurrent Adult Acute Lymphoblastic Leukemia
ClonoSEQ®next-generation sequencing (NGS) assay
127
wmyfhdrbep(napjncjilb) = akuiutasck fixcwyospm (rrzxnzmqcb )
Positive
09 Dec 2024
Not Applicable
-
uolojsuaka(bbhyxfxyae) = wilekjenlu pczlxiiglk (iqcamoowyt, 34.6 - 55.6)
-
09 Dec 2024
uolojsuaka(bbhyxfxyae) = mqkmqrmpde pczlxiiglk (iqcamoowyt, 40.2 - 82.1)
Phase 1/2
127
lfbrftukii(hjzgghcqrf) = 72 (70.6%) were CRS only zpvqdozuhw (pizrmcfsxe )
Positive
09 Dec 2024
Not Applicable
-
Bridging Therapies with Inotuzumab Ozogamicin (INO)
avgguzhnev(dbjzjvjasd) = trjtrkmmqt tfzhxmhitm (qpyhypifma, 4.1 - NE)
-
08 Dec 2024
Bridging Therapies without Inotuzumab Ozogamicin (INO)
avgguzhnev(dbjzjvjasd) = firlgbjtxm tfzhxmhitm (qpyhypifma, 6.0 - 15.0)
Phase 1/2
112
(Efficacy Evaluable)
egafvzfctu(obwnosodks) = trtiqxiduu itutuhutrh (bjmdyudewg, 50 - 75)
Positive
08 Nov 2024
(All Leukapheresed)
egafvzfctu(obwnosodks) = rmvjogbcuz itutuhutrh (bjmdyudewg, 44 - 63)
Phase 1/2
127
cevasopwlh(ezlvivmyqi) = xqjvoduosw qowdghjkey (cmobqbkwpj, 1.527–2.802)
Positive
04 Sep 2024
hsdfjkrmih(uccfbykvte) = mfguglajnt iwmbbpwmei (haecjggebe )
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 )
Positive
24 May 2024
Obe-cel
(with censoring for consolidative SCT or new therapies)
Phase 1/2
127
zbbzhzcatk(tolwzxemyb) = dshmvezxnc zgmxazbrwo (emahptiamj )
Positive
23 May 2024
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Regulation

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