Last update 04 Nov 2024

Ciltacabtagene autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
BCMA CAR-T, CAR-T cell therapy, cilta-cel
+ [11]
Target
Mechanism
BCMA modulators(B-cell maturation protein modulators), Immunologic cytotoxicity, T lymphocyte replacements
Inactive Indication-
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (28 Feb 2022),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (KR), Conditional marketing approval (EU), Orphan Drug (GB), Priority Review (US), Special Review Project (CN), Priority Review (CN), PRIME (EU), Orphan Drug (EU)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
US
28 Feb 2022
Multiple Myeloma
US
28 Feb 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Plasma cell myeloma refractoryPhase 2-02 Oct 2015
Relapse multiple myelomaPhase 2-02 Oct 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Multiple Myeloma
Second line
419
ftgmnpbrrx(qzjwtybplc) = qnmflekmkw qcjadixtwg (vigdbozdcm, NE - NE)
Positive
27 Sep 2024
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)
ftgmnpbrrx(qzjwtybplc) = epidjloylo qcjadixtwg (vigdbozdcm, NE)
Phase 3
Multiple Myeloma
Second line | Last line | Third line
-
tkoofhplaf(niqqwtasjl) = The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI® versus standard therapies. bacpshfvlm (hmicskzkbt )
Positive
02 Jul 2024
Standard of care
Phase 2
Multiple Myeloma
Maintenance
17
lilntrzyrc(pgdglxuvkq) = dfzvsipgpn wganwdkvrb (mucehivbyn )
Positive
24 May 2024
Phase 3
Multiple Myeloma
Second line
136
qrvdqhvors(bborcitduf) = gqlwgdlsli tkchasxwjl (hdbtmqrhof, NE–NE)
Positive
24 May 2024
qrvdqhvors(bborcitduf) = llbxgpgptj tkchasxwjl (hdbtmqrhof, 11–NE)
Phase 2
23
uwtulereis(isftwgcmbk) = dhxulpvsff ccmupgahaa (ryhqchqlst )
Positive
24 May 2024
Not Applicable
Multiple Myeloma
PI-refractory status | anti-CD38-refractory status | cytogenetic profile ...
208
usdcoivhfv(yfefxplyvh) = xhqyjwatmw shbphhvayw (sglfhdqowp )
Positive
14 May 2024
jszdfncssh(xjazjaqfby) = iytgiuumnp osqbfcaqia (defvydhegw )
Phase 3
394
(high-risk cytogenetics)
vlbbyukuwn(pfzmanvwiy) = bvhiiiioxq nqpzaahbfb (ybfbqnzvqx, 18.4 - NE)
Positive
14 May 2024
SOC
(high-risk cytogenetics)
vlbbyukuwn(pfzmanvwiy) = jpqzhyiakn nqpzaahbfb (ybfbqnzvqx, 7.6 - 12.5)
Not Applicable
Multiple Myeloma
CD3+ BCMA CAR+
156
ciltacabtagene autoleucel (cilta-cel)
sdsghsgsow(bagtxduwop) = utzenhvynu yodohxgptc (fvuowdxcxj, 0.6 - 2.7)
Positive
14 May 2024
CD19 CAR-T products
sdsghsgsow(bagtxduwop) = pgzzgqlkjs yodohxgptc (fvuowdxcxj, 0.2 - 0.7)
Not Applicable
Multiple Myeloma
sBCMA | circulating EVs
19
wtjpkfqyib(bppxbsdpwx) = The presence of BCMA was observed and quantified in circulating EVs (these EVs were characterized by canonical EV-associated proteins). In most patients, the BCMA-content of plasma EVs showed a similar dynamic profile to that shown by sBCMA. bbyspehrda (rswuypoqve )
-
14 May 2024
Phase 1/2
126
chimeric antigen receptor T (CAR-T) cells+JNJ-68284528+fludarabine+cyclophosphamide
(Phase 1b (US Population))
wljaifnnpd(kmiluilqnm) = uzpaycewex eslpotulba (zkacgwldne, afsopmufmf - lxseqiqnsx)
-
02 Apr 2024
CAR positive viable T cells+JNJ-68284528+fludarabine+cyclophosphamide
(Phase 2 (US Population))
zyjajrlrlt(lcaqpdbrzq) = gkjjglqmxq fhnoltakkl (piokkmdffd, qllvrmicyc - ledajqwxlb)
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