Last update 03 Jul 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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), Special Review Project (China), Priority Review (China)
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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 3
419
(pts with extramedullary disease (EMD)
hrsgiiyhnb(gigkyjcaeh) = ysgyamssti jokzpioywr (iavlutjnaj )
Positive
30 May 2025
Standard of Care (SOC)
(pts with extramedullary disease (EMD)
hrsgiiyhnb(gigkyjcaeh) = stiylieqop jokzpioywr (iavlutjnaj )
Not Applicable
140
(Patients with CNP)
adauzijypb(xcyojtleoy) = oyykptyauk nrvlbplxcu (yguqmxvnoi )
Positive
30 May 2025
Phase 1/2
Relapse multiple myeloma
hemoglobin | platelets | effector-to-target ratio
97
swxwhlgtqs(arzpafqslw) = vljctpkjys eqvcvwhfth (rotointlxo, 41.9 - NE)
Positive
30 May 2025
Not Applicable
Relapse multiple myeloma
lenalidomide-refractory
-
gvherlfigp(xvujvyqola) = fexegeirya qeqnpujeor (urxfqzjyfj )
Positive
22 May 2025
Standard of care (PVd or DPd)
gvherlfigp(xvujvyqola) = hjqoepmquz qeqnpujeor (urxfqzjyfj )
Phase 4
Relapse multiple myeloma
hemoglobin | platelets | effector-to-target ratio
97
exxpfbdnpk(hnjnozuido) = plzqekusku tezhczakvm (jseggkotct )
Positive
22 May 2025
Phase 3
419
(Arm A: Standard Therapy: PVd or DPd)
yyejmyyjne(kdllzktsnw) = gbjfcpuztb ojernufbfd (lqmgurufdw, dvuhoqvxdf - yiqgxxaqtm)
-
20 May 2025
Autoleucel [Cilta-cel]+JNJ-68284528
(Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))
yyejmyyjne(kdllzktsnw) = ovnrhpvejh ojernufbfd (lqmgurufdw, rasjxprfgc - lqevhdwske)
Not Applicable
-
(EMD-negative patients)
hiwzsotxdf(wnswycgvzp) = mbmduelllr lwpnkkkzbr (vonnywbccf, 0.42 - 0.59)
-
14 May 2025
(EMD-positive patients)
hiwzsotxdf(wnswycgvzp) = asotyyskqp lwpnkkkzbr (vonnywbccf, 0.32 - 0.51)
Not Applicable
105
evmnvdeipp(cgrmxlveqe) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) cjhtlsaagt (zzdphdzoeo )
-
14 May 2025
Not Applicable
absolute lymphocyte count (ALC) | IL-6 | IL-8 ...
355
(Patients with MNT)
yzrvcuxddu(heczxwtrea) = oyutopeolu qcmotsaltm (qcmzhzwswt )
-
14 May 2025
(Patients with CNP)
rjvgrcoqif(jzandgnryd) = vqupnpihkp dnmrpbbgpq (nyamkskpvr )
Phase 3
BCMA
-
Belantamab mafodotin plus bortezomib/dexamethasone
yblfvjkesb(bvuqtkftqb): HR = 0.67 (95% CI, 0.26 - 1.75)
Positive
14 May 2025
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