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

Phase 1

Multiple Myeloma | Small molecule | Oncology |Biohaven Ltd.|Trials Updated: Jan 20, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

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

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 340 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV18PHASE3Venetoclax, Etentamig, Elotuzumab, TNB-383B, ABBV-453
Johnson & JohnsonJNJ36PHASE3Talquetamab, Teclistamab, Bortezomib, Cilta-cel, Daratumumab
Bristol-Myers Squibb CompanyBMY21PHASE3Iberdomide, Lenalidomide, Mezigdomide, idecabtagene vicleucel, Arlocabtagene autoleucel
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK6PHASE3Gammagard Liquid, Ixazomib
GSK plc Sponsored ADRGSK26PHASE3Belantamab mafodotin, GSK3174998, Feladilimab, Dostarlimab, GSK2857916 with Pomalidomide and Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3linvoseltamab, REGN17372, Fianlimab, Cemiplimab, REGN7945
Pfizer Inc.PFE14PHASE3Elranatamab, Axitinib, Bosutinib, Crizotinib, Palbociclib
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Pegenzileukin, SAR439459, Belumosudil, SAR446523
AstraZeneca PLCAZN8PHASE3AZD0120, GC012F, AZD0305, AZD4045
Gilead Sciences, Inc.GILD4PHASE3anitocabtagene-autoleucel
Karyopharm Therapeutics, Inc.KPTI7PHASE3Selinexor
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Hoffmann-La RocheRHHBY10PHASE3Cevostamab, Tocilizumab, XmAb24306, RO7875913, RO7851624
C4 Therapeutics, Inc.CCCC3PHASE2cemsidomide
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I-131
GeoVax Labs, Inc.GOVX1PHASE2GEO-CM04S1
Incyte CorporationINCY2PHASE1Ruxolitinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax
Caribou Biosciences, Inc.CRBU2PHASE1CB-011
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Frequently asked questions about BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2

What is BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2 used for?

This combination regimen is being studied for the treatment of multiple myeloma. It combines BHV-1100, cytokine induced memory-like (CIML) NK cells, intravenous immunoglobulin (IVIG), and low dose IL-2. The approach is investigational and has been evaluated in a Phase 1 trial in patients with multiple myeloma.

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

Biohaven Ltd. (ticker: BHVN) is the developer of this combination regimen. The company is responsible for the clinical program evaluating BHV-1100 together with cytokine induced memory-like NK cells, IVIG, and low dose IL-2 in multiple myeloma.

What phase is BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2 in?

The regimen is in Phase 1 development. One Phase 1 trial has been completed. It is an investigational therapy and has not been approved by the FDA for any indication.

What clinical trials is BHV-1100 plus cytokine induced memory-like NK cells plus IVIG and low dose IL-2 in?

The regimen has been evaluated in one completed Phase 1 trial, NCT04634435, titled "Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients." The trial enrolled 7 participants in the United States and was conducted in patients with multiple myeloma.

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