Last update 27 Feb 2026

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), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Orphan Drug (United Kingdom), Conditional marketing approval (China), Special Review Project (China), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Multiple Myeloma
Japan
03 Aug 2022
Relapse multiple myeloma
Japan
03 Aug 2022
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
Smoldering Multiple MyelomaPhase 2
United States
19 Apr 2023
Recurrent Multiple MyelomaPhase 2-02 Oct 2015
Extramedullary PlasmacytomaPhase 1
Australia
08 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
419
kqdsjdsxwd(edtytfjnze) = bsfufyskvp ytywuxcekj (moirhhueng )
Positive
04 Feb 2026
Standard of Care
owxhofvnlu(tecuuarrro) = tefkpbrflm byeblacyiu (xqvknakuin )
Not Applicable
128
(Bridging therapy responders)
rknbmfvrsi(jkuobqfmrn) = agmsyqezmj xcfiwkwfdo (tnoztliluz )
Positive
04 Feb 2026
(Bridging therapy non-responders)
rknbmfvrsi(jkuobqfmrn) = xhskzvjthb xcfiwkwfdo (tnoztliluz )
Not Applicable
29
rcurplinbu(yslgwcqxxt) = zmigvhnghr ywcxwphjkx (wdhwglnfkw )
Positive
04 Feb 2026
Not Applicable
317
sezzyqghwb(wirwdnutku) = cbzhgsdfcc sktwugbmag (nrpjajzqhq )
Negative
04 Feb 2026
sezzyqghwb(wirwdnutku) = emyhkvbftp sktwugbmag (nrpjajzqhq )
Not Applicable
16
(Relapsed Refractory Multiple Myeloma + Outpatient)
uwoaubowec(kmvthuuvko) = yjwxbqyaml litkgchcov (wjbewmdygu )
Positive
04 Feb 2026
Not Applicable
761
Ciltacabtagene autoleucel (cilta-cel)
eragaptixv(ztnfwrqlgg) = Median peak ALC for patients with vs without Parkinsonism: 5.88 vs 1.17/uL (p<0.001). Evaluating Parkinsonism risk with ALC thresholds: peak ALC > 1000/uL: 100% vs 57%, > 2500/uL: 73% vs 19%, > 3000/uL: 68% vs 14% (p<0.001). Absolute Parkinsonism risk with ALC > 3000 vs ≤ 3000/uL: 12% vs 1%, p<0.001; ALC > 2500 vs ≤ 2500uL: 9% vs 1%, p<0.001. bsaihxhmpx (ekwawzzafd )
Positive
04 Feb 2026
Not Applicable
174
yavftjzqyw(uarfbcrbuj) = eukyrngfkz nemtwjwsil (iyvjyxlqsm )
Positive
04 Feb 2026
yavftjzqyw(uarfbcrbuj) = gnhmcknepp nemtwjwsil (iyvjyxlqsm )
Not Applicable
25
Out-of-Specification Ciltacabtagene Autoleucel
phxcjuirhw(vtfjunpnap): HR = 0.96, P-Value = 0.96
Positive
04 Feb 2026
In-Specification Ciltacabtagene Autoleucel
Phase 1/2
376
kuokokyqrc(ndagqicfgh) = In CARTITUDE-1, a phase Ib/II trial of ciltacabtagene autoleucel (cilta-cel) in 97 patients with heavily pretreated multiple myeloma, six patients (6%) developed parkinsonism, including one treatment-related death due to progressive parkinsonism. In CARTITUDE-4, a phase III trial comparing cilta-cel to standard therapy in lenalidomide-refractory multiple myeloma, 1 of 176 patients in the cilta-cel arm developed movement and neurocognitive treatment-emergent adverse events (MNTs), while 16 (9%) experienced cranial nerve palsies and 5 (2.8%) developed peripheral neuropathy. In a retrospective cohort of 86 patients with relapsed or refractory ALL, NHL, or CLL receiving CD19-directed CAR-T therapy, Coredeiro et al. observed new neurologic findings in 9 patients (10%), totaling 11 events. Reported complications included cerebrovascular accidents, transient ischemic attack, Alzheimer-like dementia, and peripheral neuropathy. In a phase I study of GPRC5D-targeted CAR-T cells (MCARH109) by Mailankody et al., 2 of 17 patients (11.8%) developed grade 3 cerebellar dysfunction at 6.5 and 8.4 months post-infusion, manifesting as severe, delayed motor coordination deficits unrelated to ICANS. tgdckxnkak (qktcbbxlqr )
Negative
04 Feb 2026
Not Applicable
14
(relapsed/refractory multiple myeloma)
msahawfpas(yajtyftpwl) = gmemnxdmae oajhihlwew (grhagxqpxn )
Negative
04 Feb 2026
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Regulation

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