Last update 27 Jun 2025

Satricabtagene autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
Anti-Claudin18.2-CAR-T cell therapy, CAR-CLD18 T cell therapy, CAR-CLDN18.2 T-Cells
+ [8]
Target
Action
inhibitors
Mechanism
CLDN18.2 inhibitors(Claudin 18.2 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), PRIME (European Union), Breakthrough Therapy (China), Regenerative Medicine Advanced Therapy (United States), Priority Review (China)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CLDN18.2 positive Gastroesophageal junction adenocarcinomaNDA/BLA
China
26 Jun 2025
CLDN18.2 positive Gastroesophageal junction adenocarcinomaNDA/BLA
China
26 Jun 2025
CLDN18.2 positive Stomach CancerNDA/BLA
China
26 Jun 2025
CLDN18.2 positive Stomach CancerNDA/BLA
China
26 Jun 2025
Gastroesophageal junction adenocarcinomaPhase 2
China
04 Mar 2022
Advanced Gastric AdenocarcinomaPhase 2
United States
23 Oct 2020
Advanced Gastric AdenocarcinomaPhase 2
China
23 Oct 2020
Advanced Gastric AdenocarcinomaPhase 2
Canada
23 Oct 2020
Advanced Gastroesophageal Junction AdenocarcinomaPhase 2
China
23 Oct 2020
Pancreatic CancerPhase 2
United States
23 Oct 2020
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
156
rcijjykule(otxwubrviw) = ymiwcpgxnr fypuphspwy (fviguiindk )
Positive
30 May 2025
(Treatment of Physician's Choice (TPC))
rcijjykule(otxwubrviw) = gbgaaojyvj fypuphspwy (fviguiindk )
Phase 2
156
dhlwcurkcp(cxdlovpxxu) = xevpakpvag gytalqvbec (mftzleuxrx, 2.86 - 4.53)
Positive
01 May 2025
treatment of physician's choice (TPC)
dhlwcurkcp(cxdlovpxxu) = ekxcbggivt gytalqvbec (mftzleuxrx, 1.61 - 2.04)
Not Applicable
41
tisa-cel CAR-T细胞治疗
qfgnztrdgi(qehvmszqle) = cbiserrewh xmzxyubhvq (membsexdti )
Positive
23 Jan 2025
Phase 2
Stomach Cancer
Last line | Third line
CLDN18.2 Positive
-
maysgmedhe(qnvroikgmn) = 具有统计学意义上的显著改善。 lhkyivrbxu (kaeszlwkbx )
Met
Positive
30 Dec 2024
研究者选择治疗组(包括紫杉醇、多西他赛、伊立替康、阿帕替尼或纳武利尤单抗)
Phase 1
98
kdwhekutyj(phgegrkqko) = None ssezbssbev (wwmffjxtir )
Positive
03 Jun 2024
(dose-expansion stage)
Phase 1
Gastrointestinal Neoplasms
First line
CLDN18.2 Positive
98
CT041 in pretreated pts with advanced GI cancersCT041 in pretreated pts with advanced GI cancers
rljisdkhgd(fincepydvu) = grade 3 or higher were hematologic toxicity related to lymphodepletion fifdhbgzya (nykpgwfynw )
Positive
24 May 2024
CT041 sequential treatment following first-line therapy in gastric cancer (GC)CT041 sequential treatment following first-line therapy in gastric cancer (GC)
Not Applicable
24
pcyjuamkvw(gfnsfuajki) = The most common treatment-emergent adverse events of grade 3 or more were preconditioning-related hematologic toxicities. Cytokine release syndrome (CRS) and GI disorders were most reported grade 1 or 2 adverse events. ugtvbcbwmh (zxotimeqpj )
Positive
24 May 2024
Phase 1/2
19
(GC/GEJ)
rsxteoihwr(vzwhcgbdcz) = vmjewaowjd yrmqfaspol (wjnsclrsmu )
Positive
19 Jan 2024
(DL3:600×106)
zcwajpzxra(jghnviszoc) = omcuixhuwq pnilxibynm (zaguvqldld )
Phase 1/2
14
bptazzuixs(tqxfyibvsh) = Most CRS were grade 1 or 2, and only one patient experienced grade 4 CRS and fully recovered iomgglzsjt (kpyhdpvrpz )
Positive
02 Jun 2022
Phase 1
37
tajixmqwwx(eehveirdtm) = hematologic 100% yzlvzuybss (dbebeepbie )
Positive
09 May 2022
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Regulation

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