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BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2

Phase 1

Multiple Myeloma | Cell therapy | Oncology |Biohaven Ltd.|Last Updated: Jan 20, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2 · 1 trial · 1 indication

Phase 1 1
NCT04634435Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma PatientsMultiple Myeloma
COMPLETED7 Analytics
PHASE1COMPLETED
Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
Multiple Myeloma
NCT046344357
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Study Endpoints

Primary Endpoints

Dose limiting toxicities following Combination Product administration
90-100 days post Combination Product administration
Incidence and severity of side effects related to the Combination Product
90-100 days post Combination Product administration

Secondary Endpoints

Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation
90-100 days post-ASCT
Rate of MRD conversion from positive to negative
1 year post-ASCT
Rate of MRD conversion from positive to negative at any time during the maintenance phase
Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BHV-1100 Combination TreatmentEXPERIMENTAL -

Interventions

NameTypeDescription
BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2COMBINATION_PRODUCTSingle dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Had measurable disease according to Standard Diagnostic Criteria at the time of initial Multiple Myeloma diagnosis * Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy * Is transplant eligible based on clinician judgement * Willing to undergo...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, 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
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
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
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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