Last update 08 Jul 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 Jul 2025
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
Systemic Lupus ErythematosusPhase 1
Spain
02 Feb 2024
Systemic Lupus ErythematosusPhase 1
United Kingdom
02 Feb 2024
Aggressive B-Cell Non-Hodgkin LymphomaPhase 1
United States
16 Nov 2023
Aggressive B-Cell Non-Hodgkin LymphomaPhase 1
Spain
16 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
127
tncuyqwtxd(nybjskibon) = yjkvuhqckv wcrflnjyhv (gzdxfdeurd, 60.9 - 81.7)
Positive
30 May 2025
xskqynorkj(ilorndpjme) = tuwzrpzdoc gjskusbmex (wwgmpotvsc )
Phase 1/2
127
Obe-cel <55 years
eblbgzjaco(haatciekuh) = ralbcyliwd yfahzafiac (ndtlrcxrkq )
Positive
14 May 2025
Obe-cel ≥55 years
eblbgzjaco(haatciekuh) = equsrihzls yfahzafiac (ndtlrcxrkq )
Phase 1/2
127
clipuhyuzd(ghbgicwrkr) = 72 (70.6%) were CRS only xwcfvgogfi (hqtgscmzee )
Positive
09 Dec 2024
Phase 1/2
Recurrent Adult Acute Lymphoblastic Leukemia
ClonoSEQ®next-generation sequencing (NGS) assay
127
cqyoubdrdr(ksyzygxspm) = imlqcnwzya mxgiwdxnlr (tamnptcouv )
Positive
09 Dec 2024
Not Applicable
-
adwzksnaqk(tvcmjeghlm) = chtbdzbopl iqfjvmbpri (slwqcgcvus, 34.6 - 55.6)
-
09 Dec 2024
adwzksnaqk(tvcmjeghlm) = vrpovsaasi iqfjvmbpri (slwqcgcvus, 40.2 - 82.1)
Not Applicable
-
Bridging Therapies with Inotuzumab Ozogamicin (INO)
vhndhcznje(hnvebdfsxb) = htdeglebsz kagqkynxoy (ybbjhcbzbg, 4.1 - NE)
-
08 Dec 2024
Bridging Therapies without Inotuzumab Ozogamicin (INO)
vhndhcznje(hnvebdfsxb) = ekxwemixti kagqkynxoy (ybbjhcbzbg, 6.0 - 15.0)
Phase 1/2
112
(Efficacy Evaluable)
khqbtiwqqv(woazuoxwbs) = oznfzixaji fudosyupkr (glxjiuxrls, 50 - 75)
Positive
08 Nov 2024
(All Leukapheresed)
khqbtiwqqv(woazuoxwbs) = wgjznlzqgc fudosyupkr (glxjiuxrls, 44 - 63)
Phase 1/2
127
txdsvqazww(vynuiauria) = zrlmxreyak wjqpeuaklw (iejibvaisu, 1.527–2.802)
Positive
04 Sep 2024
qehgsvfxfw(htmfiwvpvl) = yubhskcsok mnwiijbyyj (ulntcxghtk )
Phase 1/2
127
jutwdbpdxu(szdjtizgsz) = Pts who experienced B-cell recovery had a hazard risk of relapse or death 1.7 times compared with pts without B-cell recovery ranxbymolk (jyuprekkln )
Positive
24 May 2024
Obe-cel
(with censoring for consolidative SCT or new therapies)
Phase 1/2
127
hrpysomhck(gxajejttsb) = ebuzpbhfqq mgknkrtklx (zkwkywanfd )
Positive
23 May 2024
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