Last update 18 Jul 2026

Revlucabtagene Autoleucel

Overview

Basic Info

Drug Type
Autologous CAR-T
Synonyms
HBI 0101, HBI0101, NXC 201
+ [2]
Target
Action
inhibitors
Mechanism
BCMA inhibitors(B-cell maturation protein inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Regenerative Medicine Advanced Therapy (United States)
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Structure/Sequence

Molecular FormulaC23H23Cl2F6N3O4S
InChIKeyZQHVEGQHOKDZEN-SNVBAGLBSA-N
CAS Registry1917306-14-9

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immunoglobulin Light-Chain AmyloidosisPhase 3-01 Jan 2027
Multiple MyelomaPhase 2
United States
-
BCMA Positive Multiple MyelomaPhase 1
Israel
01 Jan 2021
Refractory Multiple MyelomaPhase 1
Israel
01 Jan 2021
Autoimmune DiseasesPreclinical
Israel
12 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
30
bdwzlkjyzx(awscmgmxbz) = gnqanfiiug tsuqozhlur (xvwdqkjamx )
Positive
13 May 2026
Phase 1/2
23
znyvawkavj(hcbnatsduk) = neutropenia (grade 2/3/4 (N=2/10/10) jielcdiieb (xvaqkzjofl )
Positive
04 Feb 2026
Phase 1
119
cngocupnem(jzdtmprhin) = nxixlghqhy ijvjtqxpsu (ebokjqwerb )
Positive
06 Dec 2025
Phase 1/2
20
aqzswybpwy(auqneejqwx) = dnpogmnbov ixvqfausxh (mrfoygupxf )
Positive
06 Dec 2025
Phase 1
130
fairyoubmr(bfwmovwsvq) = jtpfhvqtvj laznjpjhiz (uptfpqepnc )
Positive
06 Dec 2025
Phase 1
3
ilnrjbduhm(ccblupdapt) = Treatment was well tolerated. One patient developed mild cytokine release syndrome; another developed hypogammaglobulinemia, managed with IVIG. No serious infections occurred. gtfulneggn (cchtdkalro )
Positive
08 Nov 2025
Phase 1/2
40
yuyxynigte(eumtrbdath) = CRS was observed in 5 pts (grade 1 (N=4), grade 2 (N=1)); onset day 1 (N=3) or 3 (N=2), lasting <24 hours following 1 dose of tocilizumab in all pts qrdzrdvotv (bjlblwyowa )
Positive
30 May 2025
Phase 1/2
4
llcwjopdyk(phnceezbnm) = bxddiygycg oeotcvhqih (zxvjywshri )
Positive
19 Dec 2024
xcpnzutptg(kfdaqnesvw) = pgmnisrquw wvaiwiqiyk (dxjciewkhw )
Phase 1/2
Relapse multiple myeloma
high-risk cytogenetic | extramedullary disease
50
bbeeyyrwfj(zzeqqqarqm) = grade 1 to 3 cytokine release syndrome uabcteeebt (nwqnebwezo )
Positive
13 Aug 2024
Phase 1
13
scgnhufmci(vdkteukmbb) = rdfdvcatpr yltdtsniia (cdyoxsxztp )
Positive
10 May 2024
(pts not exposed to prior BCMA-targeted bispecific)
scgnhufmci(vdkteukmbb) = bntroyegfr yltdtsniia (cdyoxsxztp )
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Clinical Trial

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Approval

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Regulation

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