Last update 20 Mar 2025

Ciltacabtagene autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
BCMA CAR-T, CAR-T cell therapy, LCAR-B38M CAR-T cell therapy
+ [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),
RegulationConditional marketing approval (China), PRIME (European Union), Orphan Drug (Japan), Special Review Project (China), Breakthrough Therapy (United States), Priority Review (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
Multiple MyelomaPhase 3
Israel
12 Jun 2020
Relapse multiple myelomaPhase 3
Italy
12 Jun 2020
Relapse multiple myelomaPhase 3
Denmark
12 Jun 2020
Relapse multiple myelomaPhase 3
Sweden
12 Jun 2020
Relapse multiple myelomaPhase 3
Greece
12 Jun 2020
Relapse multiple myelomaPhase 3
France
12 Jun 2020
Relapse multiple myelomaPhase 3
Poland
12 Jun 2020
Relapse multiple myelomaPhase 3
Israel
12 Jun 2020
Relapse multiple myelomaPhase 3
Germany
12 Jun 2020
Relapse multiple myelomaPhase 3
Spain
12 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
86
(dnwuixvsph) = grzsmqygex inckgbxcsz (dartxtsanm, khjwqpeqsm - tsqoighbpp)
-
27 Dec 2024
Phase 3
-
(yebrzdxzfk) = wlpwgnvcbi bvkpcrldyn (ifrjliztnd )
Positive
10 Dec 2024
Standard Therapies (pomalidomide, bortezomib, dexamethasone or daratumumab, pomalidomide, dexamethasone)
(yebrzdxzfk) = kycbsrseyj bvkpcrldyn (ifrjliztnd )
Phase 3
419
(peapuarpnx) = orjsoprcwb jnnpjwackp (heghdgyqog, NE - NE)
Positive
09 Dec 2024
Standard of Care (SoC)
(peapuarpnx) = uvjgsmodmf jnnpjwackp (heghdgyqog, 25.0 - NE)
Not Applicable
-
(hzwlqmjegu) = fgiwxfxewc syglecqekh (ocprwhikna )
Similar
08 Dec 2024
(hzwlqmjegu) = atfdjhowup syglecqekh (ocprwhikna )
Not Applicable
-
(ouyyprhhbd): RR = 1.2 (95% CI, 1.06 - 1.36), P-Value = 0.0167
-
08 Dec 2024
Idecabtagene Vicleucel (ide-cel)
Phase 3
-
(hbginqtkbn) = uuohzobhjc sqyvrfiqpl (esaiadryiv, 39.92 - NR)
Positive
07 Dec 2024
Standard of Care (SOC)
(hbginqtkbn) = zxpsbbikzz sqyvrfiqpl (esaiadryiv, 32.03 - NR)
Phase 3
Multiple Myeloma
Second line
419
(rpxwbmlkjn) = synywsafyj qgoepvzkki (ondsslqfig, NE - NE)
Positive
27 Sep 2024
Pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)
(rpxwbmlkjn) = dsazfxfknp qgoepvzkki (ondsslqfig, NE)
Phase 3
Multiple Myeloma
Second line
lenalidomide-refractory | FHR MM
136
(spfvgpbipl) = aqcldjmnwy cfkxdkfiat (gcbctcejtn )
Positive
04 Sep 2024
(Standard of Care)
(spfvgpbipl) = ytapdhkbxn cfkxdkfiat (gcbctcejtn )
Phase 3
Multiple Myeloma
del(17p) | t(4;14) | t(14;16) ...
394
(dhlditfsap) = ledojbppbe nrbhkmiwyq (ubzstvbnrr )
Positive
04 Sep 2024
Standard of Care (SOC)
(dhlditfsap) = fsxkigqwag nrbhkmiwyq (ubzstvbnrr )
Phase 3
Multiple Myeloma
Second line | Last line | Third line
-
(elyhvkqswt) = The interim analysis showed a statistically significant and clinically meaningful improvement in overall survival (OS) for patients treated with CARVYKTI® versus standard therapies. vmbxbtphri (caopzmeyiq )
Positive
02 Jul 2024
Standard of care
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