Recent Updates
Recently added Catalysts

Motixafortide

Phase 1

Multiple Myeloma | Small molecule | Oncology |BioLineRx Ltd.|Last Updated: Aug 29, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Motixafortide · 1 trial · 1 indication

Phase 1 1
NCT06547112A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF MobilizationMultiple Myeloma
COMPLETED20 Analytics
PHASE1COMPLETED
A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute number and relative proportions of CD34+ cell subsets by extended immunophenotypic profiling using multicolor fluorescence activated cell sorting (mFACS) on the apheresis product
From day 5 through day 8 (up to 4 days)

Secondary Endpoints

Number of participants with adverse events
From day 4 to end of study visit (estimated to be 15-26 days)
Change in concomitant medication use
From baseline through end of study visit (estimated to be 15-26 days)
Treatment compliance
From day 4 to end of study visit (estimated to be 15-26 days)
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: Standard dosingACTIVE_COMPARATORFor Cohort 1, motixafortide will be given on Day 4 between 6:00 and 8:00 pm. A second dose may be given on Day 6 between 6:00 and 8:00 p.m. if CD34+ cell collection goals are not met on Day 5 apheresis.
Cohort 2: Early dosingEXPERIMENTALFor Cohort 2, motixafortide will be given on Day 4 between 2:00 and 4:00 pm. A second dose may be given on Day 6 with goal of administration between 6:00 and 8:00 pm after completion of pheresis if clinically feasible. if CD34+ cell collection goals are not met on Day 5 apheresis.

Interventions

NameTypeDescription
MotixafortideDRUGDose = 1.25 mg/kg via subcutaneous injection
G-CSFDRUGDose = \~10 µg/kg (and maximum of 15 µg/kg) via subcutaneous injection
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 78 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must be between the ages of 18 and 78 years, inclusive. * Histologically confirmed multiple myeloma expected to receive high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT) * Received ≥3 cycles but ≤6 cycles of daratumumab-based quadruplet indu...

Countries:United States
Unlock Eligibility Criteria

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
Unlock Competitive Intelligence

Frequently asked questions about Motixafortide

What is Motixafortide used for in Multiple Myeloma?

Motixafortide is an investigational small molecule being studied for use in Multiple Myeloma. It is being evaluated as part of a mobilization regimen, specifically following quad-induction therapy, to enhance the collection of stem cells for apheresis. The drug is currently in Phase 1 clinical development and is not yet approved.

What does Motixafortide target?

Motixafortide is a small molecule that targets the CXCR4 receptor, which plays a role in stem cell mobilization. By blocking this receptor, it aims to release stem cells from the bone marrow into the bloodstream, facilitating their collection for transplantation in Multiple Myeloma patients.

Who is developing Motixafortide?

Motixafortide is being developed by BioLineRx Ltd., a biopharmaceutical company. BioLineRx is publicly traded under the ticker symbol BLRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Multiple Myeloma.

What phase is Motixafortide in?

Motixafortide is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing research is focused on assessing its pharmacodynamic effects and safety profile in patients with Multiple Myeloma.

What clinical trials is Motixafortide in?

Motixafortide has been studied in a Phase 1 clinical trial with the identifier NCT06547112. This completed trial, titled 'A Pharmacodynamic Study of the Apheresis Product of Multiple Myeloma Patients Undergoing Quad-induction Followed by Motixafortide + G-CSF Mobilization,' enrolled 20 participants in the United States.

Is Motixafortide the same as other drugs?

Motixafortide is also known by other names, including BL-8040 and BKT140. These alternative names may be used in scientific literature and clinical trial registries. Regardless of the name, they refer to the same investigational small molecule being developed by BioLineRx for Multiple Myeloma.