Last update 19 Dec 2024

Ciltacabtagene autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
BCMA CAR-T, CAR-T cell therapy, cilta-cel
+ [12]
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),
RegulationPriority Review (US), Orphan Drug (EU), PRIME (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (KR), Conditional marketing approval (EU), Orphan Drug (GB), Special Review Project (CN), Breakthrough Therapy (US), Orphan Drug (US)
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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
Relapse multiple myelomaPhase 3
US
12 Jun 2020
Relapse multiple myelomaPhase 3
JP
12 Jun 2020
Relapse multiple myelomaPhase 3
AU
12 Jun 2020
Relapse multiple myelomaPhase 3
BE
12 Jun 2020
Relapse multiple myelomaPhase 3
DK
12 Jun 2020
Relapse multiple myelomaPhase 3
FR
12 Jun 2020
Relapse multiple myelomaPhase 3
DE
12 Jun 2020
Relapse multiple myelomaPhase 3
GR
12 Jun 2020
Relapse multiple myelomaPhase 3
IL
12 Jun 2020
Relapse multiple myelomaPhase 3
IT
12 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Ciltacabtagene Autoleucel 0.5 x 10^6 CAR-positive T-cells/kg
jdcqpjylng(yjxscfimqr) = One patient experienced grade 1 Bell’s palsy that was self-limiting and resolved within 2 weeks nzkfhsmfxj (xjrnxvatza )
-
09 Dec 2024
Ciltacabtagene Autoleucel 0.75 x 10^6 CAR-positive T-cells/kg
Not Applicable
-
ezgpiuyusb(vxcgcxcqow): RR = 1.2 (95% CI, 1.06 - 1.36), P-Value = 0.0167
-
08 Dec 2024
Idecabtagene Vicleucel (ide-cel)
Phase 3
Multiple Myeloma
del(17p) | t(4;14) | t(14;16) ...
394
eaybmgcfir(udtwwiwvxc) = ifvdorfays nifhaiosvr (uihelbqevi )
Positive
04 Sep 2024
Standard of Care (SOC)
eaybmgcfir(udtwwiwvxc) = fcsiszteyn nifhaiosvr (uihelbqevi )
Not Applicable
Multiple Myeloma
Second line
lenalidomide-refractory | FHR MM
136
hoitexaqoi(hfmrhkfhmi) = hrzagatjtj sfhpvcwwmy (hlbacoddkz )
Positive
04 Sep 2024
(Standard of Care)
hoitexaqoi(hfmrhkfhmi) = zdlshvwhld sfhpvcwwmy (hlbacoddkz )
Not Applicable
-
Cilta-cel infusion
ejmetwmpnt(kblxbsmhpx) = 82%; all grade 1/2; median time to onset [recovery], 8 d [3 d] lxztopnccl (msinfqaqtn )
-
04 Sep 2024
Cilta-cel infusion + Lenalidomide maintenance
Not Applicable
Multiple Myeloma
PI-refractory status | anti-CD38-refractory status | cytogenetic profile ...
208
lzxqkawfpx(rzkzjjhxwm) = zdxtakiqep iktlcfcqes (cqmzhkjlyq )
Positive
14 May 2024
(Real-world physician’s choice of treatment (RWPC))
remklbqxth(pjnugzquoq) = kxkzhwaxhd ujdnogmlll (tammwafyze )
Not Applicable
Multiple Myeloma
CD3+ BCMA CAR+
156
ciltacabtagene autoleucel (cilta-cel)
bzcwsiwwuu(yjbhkjjqnm) = glqewmwusn zwrbzqepwv (xntidkspph, 0.6 - 2.7)
Positive
14 May 2024
CD19 CAR-T products
bzcwsiwwuu(yjbhkjjqnm) = pvqfodikci zwrbzqepwv (xntidkspph, 0.2 - 0.7)
Not Applicable
Multiple Myeloma
sBCMA | circulating EVs
19
dtioykcqpb(wiubqzsekr) = 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. wenwilbjpc (gkvylyfpgk )
-
14 May 2024
Not Applicable
43
Ciltacabtagene Autoleucel of Ciltacabtagene Autoleucel
uogwxtzwai(tixjufkdje) = hhkzolqlyi vqnyvpseyh (atsnewqthk, 76.5 - 99.5)
Positive
01 Feb 2024
Not Applicable
332
Ciltacabtagene Autoleucel (Cilta-cel)
cswgptxkpx(qqlbyvwibf) = Of N=332 receiving cilta-cel across trials, 21 (6.3%) developed CNP; most cases were grade (gr) 2 (n=3 gr 3). 6 pts had CNP on both sides; most unilateral impairments were left-sided. Median time to onset was 22 days (d; range, 17-101). All pts had CN VII involvement; 2 had additional CNs involved (1 CN III [gr 3], 2 CN V [gr 3]). 12 pts had concurrent neurologic symptoms/neurotoxicities.Clinical characteristics of pts with or without CNP were comparable. In n=21 with CNP, median age was 64 years; 81% were male; at baseline, 1 pt had high disease burden (bone marrow 95% plasma cells), 4 had plasmacytomas (1 bone based); 1 pt had ISS stage III. Most responded to bridging therapy. 6 pts had an infection before CNP onset after cilta-cel infusion (bacterial, n=5; cytomegalovirus, n=2; both, n=1); CRS rate was comparable between groups. Of pts with CNP, 90% had preceding CRS (all gr 1/2; median onset, d 7; median duration, 3 d); 13 received tocilizumab for CRS. 1 pt had preceding gr 2 ICANS; none had movement/neurocognitive treatment-related adverse events at any time.Brain MRI and CSF analysis in 14 and 17 pts, respectively, demonstrated no evidence of infectiousor malignant etiology. Facial nerve enhancement was shown with MRI in 7 pts. Most cases were treated with corticosteroids for median 13 d. In 19/21 pts, CNP resolved within median 66 d, including the 3 pts with gr-3 CNP.In CARTITUDE-4, pts with CNP had significantly higher levels of CAR+ T-cell expansion and greater exposure to CAR+ T cells (AUC0-CNP onset) than those without (Figure). Pts with CNP trended toward higher peak concentration and exposure level (AUC0-CNP onset) of IL-6, IL-10, and IL-2Rα, but not in IFNγ. Differentiation pattern of memory T cells from apheresis to peak CAR+ T expansion (Tmax) was comparable; CAR+ T cells at Tmax were dominant with central memory T cells in both groups. cyizliwbkv (fqgukysozn )
Positive
01 Feb 2024
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