Recent Updates
Recently added Catalysts

LUCAR-B68 cells product

Phase 1

Relapsed/Refractory Multiple Myeloma | Monoclonal antibody | Oncology |Legend Biotech Corporation|Last Updated: Aug 12, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05498545Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple MyelomaPHASE1 NOT YET_RECRUITING 34Sep 1, 2022Mar 1, 2027Aug 12, 20221 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Minimum 2 years after LUCAR-B68 infusion (Day 1

An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment

Dose-limiting toxicity (DLT) rate
Minimum 2 years after LUCAR-B68 infusion (Day 1)

Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose

Recommended Phase 2 dose (RP2D) finding
30 days after LUCAR-B68 infusion (Day 1)

RP2D established through ATD+BOIN design

CAR positive NK cells in peripheral blood and bone marrow
Minimum 2 years after LUCAR-B68 infusion (Day 1)

CAR positive NK cells in peripheral blood and bone marrow after LUCAR-B68 infusion

CAR transgene levels in peripheral blood
Minimum 2 years after LUCAR-B68 infusion (Day 1)

CAR transgene levels in peripheral blood after LUCAR-B68 infusion

Secondary Endpoints
Overall response rate (ORR)
Minimum 2 years after LUCAR-B68 infusion (Day 1)
Duration of Response (DOR)
Minimum 2 years after LUCAR-B68 infusion (Day 1)
Time to Response (TTR)
Minimum 2 years after LUCAR-B68 infusion (Day 1)
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LUCAR-B68 cells productEXPERIMENTALEach subject will receive LUCAR-B68 cells
Interventions
NameTypeDescription
LUCAR-B68 cells productBIOLOGICALBefore treatment with LUCAR-B68 cells, subjects will receive a conditioning regimen
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiatin...

Countries:China
Unlock Eligibility Criteria
Competitive Landscape -Multiple Myeloma 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol / Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
Unlock Competitive Intelligence
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05498545studyFirstPostDate: changed