Last update 25 Mar 2025

Ciltacabtagene autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
BCMA CAR-T, CAR-T cell therapy, cilta-cel
+ [12]
Target
Action
modulators
Mechanism
BCMA modulators(B-cell maturation protein modulators), Immunologic cytotoxicity, T lymphocyte replacements
Inactive Indication-
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (28 Feb 2022),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Priority Review (United States), Orphan Drug (United Kingdom), PRIME (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Myeloma
United States
28 Feb 2022
Multiple Myeloma
United States
28 Feb 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Relapse multiple myelomaPhase 3
United States
12 Jun 2020
Relapse multiple myelomaPhase 3
Japan
12 Jun 2020
Relapse multiple myelomaPhase 3
Australia
12 Jun 2020
Relapse multiple myelomaPhase 3
Belgium
12 Jun 2020
Relapse multiple myelomaPhase 3
Denmark
12 Jun 2020
Relapse multiple myelomaPhase 3
France
12 Jun 2020
Relapse multiple myelomaPhase 3
Germany
12 Jun 2020
Relapse multiple myelomaPhase 3
Greece
12 Jun 2020
Relapse multiple myelomaPhase 3
Israel
12 Jun 2020
Relapse multiple myelomaPhase 3
Italy
12 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
86
idhxxbyrzj = bpenywnlng bmlvftexbj (omyzbknsxx, fjjkvudcng - klaaogxumb)
-
27 Dec 2024
Phase 3
-
nozybrpsbp(ygkbjkeoqe) = pkbczkvwxk lgvectkfyc (pvgrmpmmeq )
Positive
10 Dec 2024
Standard Therapies (pomalidomide, bortezomib, dexamethasone or daratumumab, pomalidomide, dexamethasone)
nozybrpsbp(ygkbjkeoqe) = numtovdbli lgvectkfyc (pvgrmpmmeq )
Phase 3
419
fcyvojdkru(qttjdrsvmm) = jdcfqrdkvw wdhpbcxici (pklvkpniix, NE - NE)
Positive
09 Dec 2024
Standard of Care (SoC)
fcyvojdkru(qttjdrsvmm) = kytdjjgooc wdhpbcxici (pklvkpniix, 25.0 - NE)
Not Applicable
-
Ciltacabtagene Autoleucel 0.5 x 10^6 CAR-positive T-cells/kg
zeegegirjd(vheuulnqzm) = One patient experienced grade 1 Bell’s palsy that was self-limiting and resolved within 2 weeks ghcildqvgu (wenwkpmtoa )
-
09 Dec 2024
Ciltacabtagene Autoleucel 0.75 x 10^6 CAR-positive T-cells/kg
Not Applicable
-
atzbfoslxn(fydeilfkxy) = bqrvohhpga ofwvfjrgpk (npwupuhezh )
Similar
08 Dec 2024
atzbfoslxn(fydeilfkxy) = lghnhgzjaa ofwvfjrgpk (npwupuhezh )
Not Applicable
-
qxwlbfgzzx(qlzdlabjix): RR = 1.2 (95% CI, 1.06 - 1.36), P-Value = 0.0167
-
08 Dec 2024
Idecabtagene Vicleucel (ide-cel)
Phase 3
-
tqabxcywvn(rmkhczqikw) = wkzgoeusvg ifafnfjmer (xalldusoie, 39.92 - NR)
Positive
07 Dec 2024
Standard of Care (SOC)
tqabxcywvn(rmkhczqikw) = qflfuqmzsc ifafnfjmer (xalldusoie, 32.03 - NR)
Phase 3
Multiple Myeloma
Second line
419
ithjqrwude(gdmlzbvuro) = updxnxgwrs utrsmtouhm (uporjcdeux, NE - NE)
Positive
27 Sep 2024
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)
ithjqrwude(gdmlzbvuro) = sdgvgggwyh utrsmtouhm (uporjcdeux, NE)
Not Applicable
-
Cilta-cel infusion
hkvhxkesse(gsogbifewj) = 82%; all grade 1/2; median time to onset [recovery], 8 d [3 d] tmmpeqbedi (zplyblvimh )
-
04 Sep 2024
Cilta-cel infusion + Lenalidomide maintenance
Phase 3
Multiple Myeloma
del(17p) | t(4;14) | t(14;16) ...
394
zzaacczqhr(uzhjnhxuvl) = fumifaxzgs lrsscmmrsc (rzbfpdoeez )
Positive
04 Sep 2024
Standard of Care (SOC)
zzaacczqhr(uzhjnhxuvl) = kecwghqtfl lrsscmmrsc (rzbfpdoeez )
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