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Linvoseltamab

Phase 3

High Risk Smoldering Multiple Myeloma (HR-SMM) | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 21, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment270

FDA Designations

PRIORITY_REVIEWACCELERATED_APPROVAL

Clinical trial landscape

Linvoseltamab · 14 trials · 9 indications

Phase 3 3Phase 2 4Phase 1 7
NCT07393282A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)High Risk Smoldering Multiple Myeloma (HR-SMM)
RECRUITING270 Analytics
NCT07222761A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)Relapsed and/or Refractory Multiple Myeloma (RRMM)
RECRUITING915 Analytics
NCT05730036A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple MyelomaRelapsed Refractory Multiple Myeloma (RRMM)
RECRUITING410 Analytics
PHASE3RECRUITING
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
NCT07393282270
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PHASE3RECRUITING
A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT07222761915
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PHASE3RECRUITING
A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma
Relapsed Refractory Multiple Myeloma (RRMM)
NCT05730036410
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Study Endpoints

Primary Endpoints

Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
Up to 5 years
Biochemical PFS per IMWG criteria
Up to 5 years
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 5 years

Part 1

Severity of TEAEs
Up to 5 years

Part 1

Occurrence of Adverse Events of Special Interest (AESI)
Up to 5 years

Part 1

Severity of AESIs
Up to 5 years

Part 1

Occurrence of Serious Adverse Events (SAEs)
Up to 5 years

Part 1

Severity of SAEs
Up to 5 years

Part 1

Minimal Residual Disease (MRD)-negative Complete Response (CR)
At 12 months

Part 2

Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC
Up to 5 years

Part 2

Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants
Up to approximatively 5 years
Minimum Residual Disease Negative Conversion Rate
12 months

The number of patients who experience MRD negativity (10\^-5 sensitivity by 12 cycles of linvoseltamab (MRD conversion rate) will be determined by dividing this number of MRD negative responses by the total number of evaluable patients. MRD negativity rate (\<10\^-5) by 12 cycles of linvoseltamab

Minimal Residual Disease (MRD) Negativity Rate
Up to 6 months

The rate of MRD-negativity among participants. Defined by rate of MRD negativity using clonoSEQ MRD® assay at sensitivities of 10\^-5 and 10\^-6. MRD negativity is defined as 0 residual clonal cells in a bone marrow biopsy sample

Frequency of Adverse Events Interest (AEI) during the safety observation period
35 days

Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules

Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period
35 days

Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)

Severity of TEAEs during the safety observation period
35 days

Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)

Achievement of Complete Response (CR) as determined by the investigator
Up to 5.5 years

Part 2

Frequency of Adverse Events of Special Interest (AESI) during the safety run-in observation period
Up to 35 days

AESI include grade 2 or higher Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)

Frequency of Treatment-Emergent Adverse Events (TEAEs) during the safety run-in observation period
Up to 35 days
Severity of TEAEs during the safety run-in observation period
Up to 35 days
Complete Response (CR) as determined by the investigator
Up to 7 years
Minimal Residual Disease (MRD) negativity
At 12 months
MRD negativity
At 24 months
Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab
Up to 35 days

Phase 1

Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab
Up to 5 years

Phase 1

Severity of TEAEs associated with REGN17372 in combination with linvoseltamab
Up to 5 years

Phase 1

Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination study drugs
Within 12 weeks of starting cycle 1

Phase 2

VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy
Within 12 weeks of starting cycle 1

Phase 2

Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs
Within 12 weeks of starting cycle 1

Phase 2

PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy
Within 12 weeks of starting cycle 1

Phase 2

Incidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab
Up to 21 days

Phase 1

Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab
Up to 5 years

Phase 1

Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab
Up to 5 years

Phase 1

Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination therapy
Within 12 weeks of starting cycle 1

Phase 2

Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy
Within 12 weeks of starting cycle 1

Phase 2

Incidence of dose-limiting toxicity (DLTs)
Up to 28 Days

Phase 1

Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC)
Up to 3 years

Phase 2

Incidence of Treatment-Emergent Adverse Events (TEAEs)
From the initial first dose of linvoseltamab through the end of week 30
Incidence of Adverse Event of Special Interest (AESIs)
From the initial first dose of linvoseltamab through the end of week 30
Incidence of Serious Adverse Events (SAEs)
From the initial first dose of linvoseltamab through the end of week 30
Incidence of Dose-Limiting Toxicities (DLTs)
End of the Observation period; up to day 28

Phase 1

Incidence of Adverse Events of Special Interest (AESIs)
Post-Last Linvoseltamab Dose, up to 90 days

Phase 1

Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
Up to 5 years

Phase 2

Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
Up to 5 years

Phase 2 Transplant-eligible cohort

Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
Up to 5 years

Phase 2 Transplant-eligible cohort

Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
Up to 5 years

Phase 2 Transplant-ineligible cohort

Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
Up to 5 years

Phase 2 Transplant ineligible cohort

Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period
Up to 28 Days

Dose finding portion only

Incidence of laboratory abnormalities
Up to 5 Years

≥ grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE v5.0\]

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Up to 28 days

Phase 1 and Phase 2 for Japanese cohort only

Incidence and severity of treatment-emergent adverse events (TEAEs)
Up to 5 years

Phase 1

Incidence and severity of adverse events of special interest (AESI)
Up to 5 years

Phase 1

Assessment of the pharmacokinetics (PK) of linvoseltamab
Up to 5 years

Phase 1 part 2

Concentrations of linvoseltamab in serum over time
Up to 5 years

Phase 2, for Japanese cohort only

Objective response rate (ORR) as determined by an Independent Review Committee (IRC)
Up to 5 years

Phase 2, cohorts 1 and 2

Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab
Up to 5 years

Phase 2, cohort 3

ORR of IV linvoseltamab as assessed by investigator
Up to 5 years

Phase 2, cohort 3

Secondary Endpoints

Achievement of Minimal Residual Disease (MRD) Complete Response (CR) at 10^-5 per IMWG criteria
Up to 3 years
Time to death
Up to 9 years
Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria
Up to 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LinvoseltamabEXPERIMENTAL -
DaratumumabACTIVE_COMPARATOR -
Part 1: Arm AEXPERIMENTAL -
Part 1: Arm BEXPERIMENTAL -
Part 2: Arm AEXPERIMENTAL -
Part 2: Arm BEXPERIMENTAL -
Part 2: Arm CEXPERIMENTAL -
Elotuzumab/Pomalidomide/Dexamethasone (EPd)ACTIVE_COMPARATORRandomization 1:1
Cohort 1 - Linvoseltamab Treatment GroupEXPERIMENTALParticipants in this group are currently receiving lenalidomide maintenance therapy for ≤12 months will have linvoseltamab added to the lenalidomide maintenance therapy and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years
Cohort 2 - Lenalidomide Treatment GroupEXPERIMENTALParticipants in this group are currently receiving lenalidomide maintenance therapy but have relapsed disease within 12 months of starting maintenance will have Linvoseltamab added to lenalidomide maintenance and receive treatment with the combination for up to 24 cycles. Total participation duration is up to 4.5 years
Linvoseltamab GroupEXPERIMENTALParticipants in this group will be administered a fixed duration of Linvoseltamab for four to six 28-day cycles, depending on minimal residual disease (MRD) conversion status. After four cycles, participants that are MRD-negative will no longer receive study treatment. Participants that are MRD-positive will receive an additional two cycles of Linvoseltamab. Total participation duration is up to 3 years.
Safety Run-In (Part 1)EXPERIMENTALSequential groups of participants will be enrolled to assess the initial safety and tolerability of the step-up regimen leading up to the start of different full doses of linvoseltamab.
Expansion (Part 2) - Dose regimen 1EXPERIMENTALParticipants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 2EXPERIMENTALParticipants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 3EXPERIMENTALParticipants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 4EXPERIMENTALParticipants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2)EXPERIMENTAL -
REGN17372 + LinvoseltamabEXPERIMENTALPhase 1 Phase 2
Linvoseltamab monotherapyACTIVE_COMPARATORPhase 2
REGN7945+LinvoseltamabEXPERIMENTALPhase 1 Phase 2
Phase 1: Cohort 1: Low DoseEXPERIMENTALDose Escalation: Non-Randomized
Phase 1: Cohort 2: High DoseEXPERIMENTALDose Escalation: Non-Randomized
Phase 2: Low DoseEXPERIMENTALDose Expansion: Participants will be randomized in a 1:1 ratio
Phase 2: High DoseEXPERIMENTALDose Expansion: Participants will be randomized in a 1:1 ratio
Severe IgE-mediated food allergyEXPERIMENTAL -
Phase 1 cohortsEXPERIMENTALLinvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.
Phase 2 - transplant ineligible cohortEXPERIMENTALTransplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
Phase 2 - transplant eligible cohortEXPERIMENTALTransplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
Cohort 1: Linvoseltamab + DaratumumabEXPERIMENTALLinvoseltamab + Daratumumab
Cohort 2: Linvolseltamab + CarfilzomibEXPERIMENTALLinvoseltamab + Carfilzomib
Cohort 3: Linvoseltamab + LenalidomideEXPERIMENTALLinvoseltamab + Lenalidomide
Cohort 4: Linvoseltamab + BortezomibEXPERIMENTALLinvoseltamab + Bortezomib
Cohort 5: Linvoseltamab + PomalidomideEXPERIMENTALLinvoseltamab + Pomalidomide
Cohort 6: Linvoseltamab + IsatuximabEXPERIMENTALLinvoseltamab + Isatuximab
Cohort 7: Linvoseltamab + FianlimabEXPERIMENTALLinvoseltamab + Fianlimab
Cohort 8: Linvoseltamab + CemiplimabEXPERIMENTALLinvoseltamab + Cemiplimab
Cohort 9: Linvoseltamab + NirogacestatEXPERIMENTALLinvoseltamab + Nirogacestat
Cohort 10: Linvoseltamab + CevostamabEXPERIMENTALLinvoseltamab + Cevostamab
Linvoseltamab - Phase 1EXPERIMENTALPhase 1 has two parts. Part 1, consists of linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration.
Linvoseltamab - Phase 2 - Cohort 1EXPERIMENTALLow Dose of linvoseltamab IV monotherapy.
Linvoseltamab - Phase 2 - Cohort 2EXPERIMENTALHigh Dose of linvoseltamab IV monotherapy.
Linvoseltamab - Phase 2 - Cohort 3EXPERIMENTALAnti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy.

Interventions

NameTypeDescription
LinvoseltamabDRUGAdministered per the protocol
DaratumumabDRUGAdministered per the protocol
CarfilzomibDRUGAdministered per the protocol
DexamethasoneDRUGAdministered per the protocol
PomalidomideDRUGAdministered per the protocol
BortezomibDRUGAdministered per the protocol
ElotuzumabDRUGElotuzumab will be administered by IV infusion
LenalidomideDRUGParticipants will take 10mg of Lenalidomide maintenance therapy standard of care by mouth daily from days 1 through 21 of each 28 day cycle of Linvoseltamab therapy. Lenalidomide therapy will begin on Cycle 2 Day 1 of Linvoseltamab therapy.
REGN17372+LinvoseltamabDRUGAdministered per the protocol
REGN7945+LinvoseltamabDRUGAdministered per protocol
dupilumabDRUGAdministered by subcutaneous (SC) injection
IsatuximabDRUGAdministered per the protocol
FianlimabDRUGAdministered per the protocol
CemiplimabDRUGAdministered per the protocol
NirogacestatDRUGAdministered per the protocol
CevostamabDRUGAdministered per the protocol
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group performance status score ≤1 2. SMM diagnosis per IMWG criteria as defined in the protocol 3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol Key Exclusion Criteria: 1. Evidence of myeloma-defining events attrib...

Countries:United StatesAustraliaSouth KoreaUnited KingdomBelgiumBrazilCanadaChileFranceGermanyIsraelItalyJapanNetherlandsPolandSingaporeSpainTaiwanIrelandGreece
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Recent Changes (Last 90 Days)

LOWAug 21, 2026NCT07455851lastUpdatePostDate: changed
LOWAug 21, 2026NCT07455851lastUpdatePostDate: changed
LOWAug 18, 2026NCT07393282lastUpdatePostDate: changed
LOWAug 18, 2026NCT06292780lastUpdatePostDate: changed
LOWAug 18, 2026NCT06292780lastUpdatePostDate: changed
LOWAug 18, 2026NCT07393282lastUpdatePostDate: changed
LOWAug 7, 2026NCT07393282lastUpdatePostDate: changed
LOWAug 7, 2026NCT07393282lastUpdatePostDate: changed
LOWAug 5, 2026NCT06669247lastUpdatePostDate: changed
LOWAug 5, 2026NCT07455851lastUpdatePostDate: changed
MEDIUMJul 8, 2026NCT05137054primaryCompletionDate: changed
LOWJul 8, 2026NCT06140524lastUpdatePostDate: changed
LOWJul 8, 2026NCT07393282lastUpdatePostDate: changed
LOWJul 8, 2026NCT07455851lastUpdatePostDate: changed
MEDIUMJul 8, 2026NCT05137054primaryCompletionDate: changed
LOWJul 8, 2026NCT06140524lastUpdatePostDate: changed
LOWJul 8, 2026NCT07393282lastUpdatePostDate: changed
LOWJul 8, 2026NCT07455851lastUpdatePostDate: changed
LOWJul 2, 2026NCT07222761lastUpdatePostDate: changed
LOWJul 2, 2026NCT07222761lastUpdatePostDate: changed

Frequently asked questions about Linvoseltamab

What is Linvoseltamab used for?

Linvoseltamab is an investigational bispecific antibody being studied for multiple myeloma and related plasma cell disorders, including relapsed/refractory multiple myeloma (RRMM), relapsed/refractory systemic light chain amyloidosis, and smoldering multiple myeloma (SMM). It is being evaluated in clinical trials for these conditions.

What does Linvoseltamab target?

Linvoseltamab is a bispecific antibody that targets both BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T cells, thereby redirecting T cells to kill myeloma cells. This mechanism is being studied in clinical trials for the treatment of multiple myeloma and related conditions.

Who is developing Linvoseltamab?

Linvoseltamab is being developed by Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in patients with multiple myeloma and related plasma cell disorders.

What phase is Linvoseltamab in?

Linvoseltamab is in Phase 3 clinical development for relapsed/refractory multiple myeloma. It has received FDA Priority Review and Accelerated Approval designations, indicating it is being reviewed under expedited pathways. The drug is still investigational and not yet approved for commercial use.

What clinical trials is Linvoseltamab in?

Linvoseltamab is being studied in several clinical trials, including NCT05730036 (Phase 3, comparing to elotuzumab, pomalidomide, and dexamethasone in RRMM), NCT06292780 (Phase 1, in relapsed/refractory AL amyloidosis), NCT07222761 (Phase 3, comparing monotherapy and combination with carfilzomib), and NCT07455851 (Phase 1, in combination with REGN17372).

Is Linvoseltamab the same as REGN5458?

Linvoseltamab is also known as REGN5458. It is a bispecific antibody being developed by Regeneron Pharmaceuticals for the treatment of multiple myeloma and related conditions. The drug is currently in Phase 3 clinical trials for relapsed/refractory multiple myeloma.