Recently added Catalysts

linvoseltamab

Phase 4FDA approved 2025

High Risk Smoldering Multiple Myeloma (HR-SMM) | Monoclonal antibody | Oncology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Oct 8, 2026

linvoseltamab development status

FDA approval Jul 2, 2025 as Lynozyfic

Approval holderRengeneron Pharmaceuticals, Inc.

ApplicationBLA761400

Highest phase Phase 4 (NCT07609940)

Phase scored for REGNPhase 3

Registered trials 20 across 5 sponsors since Dec 2018

Label indication LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . FDA label

linvoseltamab target and mechanism

Molecular targetCD3/BCMA

Target class-Mab (Antibody)

ModalityMonoclonal antibody

Also known as REGN5458, Lynozyfic™, BCMAxCD3

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC

Total Trials14

Total Enrollment3,226

FDA Designations

PRIORITY_REVIEWACCELERATED_APPROVAL

linvoseltamab clinical trials

linvoseltamab · 14 trials · 9 indications

Phase 3 3Phase 2 4Phase 1 7

Indication

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

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

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

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

Arm	Type	Description
Linvoseltamab	EXPERIMENTAL	-
Daratumumab	ACTIVE_COMPARATOR	-
Part 1: Arm A	EXPERIMENTAL	-
Part 1: Arm B	EXPERIMENTAL	-
Part 2: Arm A	EXPERIMENTAL	-
Part 2: Arm B	EXPERIMENTAL	-
Part 2: Arm C	EXPERIMENTAL	-
Elotuzumab/Pomalidomide/Dexamethasone (EPd)	ACTIVE_COMPARATOR	Randomization 1:1
Linvoseltamab Group	EXPERIMENTAL	Participants 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.
Cohort 1 - Linvoseltamab Treatment Group	EXPERIMENTAL	Participants 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 Group	EXPERIMENTAL	Participants 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
Safety Run-In (Part 1)	EXPERIMENTAL	Sequential 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 1	EXPERIMENTAL	Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 2	EXPERIMENTAL	Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 3	EXPERIMENTAL	Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2) - Dose regimen 4	EXPERIMENTAL	Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
Expansion (Part 2)	EXPERIMENTAL	-
REGN17372 + Linvoseltamab	EXPERIMENTAL	Phase 1 Phase 2
Linvoseltamab monotherapy	ACTIVE_COMPARATOR	Phase 2
REGN7945+Linvoseltamab	EXPERIMENTAL	Phase 1 Phase 2
Phase 1: Cohort 1: Low Dose	EXPERIMENTAL	Dose Escalation: Non-Randomized
Phase 1: Cohort 2: High Dose	EXPERIMENTAL	Dose Escalation: Non-Randomized
Phase 2: Low Dose	EXPERIMENTAL	Dose Expansion: Participants will be randomized in a 1:1 ratio
Phase 2: High Dose	EXPERIMENTAL	Dose Expansion: Participants will be randomized in a 1:1 ratio
Severe IgE-mediated food allergy	EXPERIMENTAL	-
Phase 1 cohorts	EXPERIMENTAL	Linvoseltamab 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 cohort	EXPERIMENTAL	Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
Phase 2 - transplant eligible cohort	EXPERIMENTAL	Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
Cohort 1: Linvoseltamab + Daratumumab	EXPERIMENTAL	Linvoseltamab + Daratumumab
Cohort 2: Linvolseltamab + Carfilzomib	EXPERIMENTAL	Linvoseltamab + Carfilzomib
Cohort 3: Linvoseltamab + Lenalidomide	EXPERIMENTAL	Linvoseltamab + Lenalidomide
Cohort 4: Linvoseltamab + Bortezomib	EXPERIMENTAL	Linvoseltamab + Bortezomib
Cohort 5: Linvoseltamab + Pomalidomide	EXPERIMENTAL	Linvoseltamab + Pomalidomide
Cohort 6: Linvoseltamab + Isatuximab	EXPERIMENTAL	Linvoseltamab + Isatuximab
Cohort 7: Linvoseltamab + Fianlimab	EXPERIMENTAL	Linvoseltamab + Fianlimab
Cohort 8: Linvoseltamab + Cemiplimab	EXPERIMENTAL	Linvoseltamab + Cemiplimab
Cohort 9: Linvoseltamab + Nirogacestat	EXPERIMENTAL	Linvoseltamab + Nirogacestat
Cohort 10: Linvoseltamab + Cevostamab	EXPERIMENTAL	Linvoseltamab + Cevostamab
Linvoseltamab - Phase 1	EXPERIMENTAL	Phase 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 1	EXPERIMENTAL	Low Dose of linvoseltamab IV monotherapy.
Linvoseltamab - Phase 2 - Cohort 2	EXPERIMENTAL	High Dose of linvoseltamab IV monotherapy.
Linvoseltamab - Phase 2 - Cohort 3	EXPERIMENTAL	Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy.

Interventions

Name	Type	Description
Linvoseltamab	DRUG	Administered per the protocol
Daratumumab	DRUG	Administered per the protocol
Carfilzomib	DRUG	Administered per the protocol
Dexamethasone	DRUG	Administered per the protocol
Pomalidomide	DRUG	Administered per the protocol
Bortezomib	DRUG	Administered per the protocol
Elotuzumab	DRUG	Elotuzumab will be administered by IV infusion
Lenalidomide	DRUG	Participants 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+Linvoseltamab	DRUG	Administered per the protocol
REGN7945+Linvoseltamab	DRUG	Administered per protocol
dupilumab	DRUG	Administered by subcutaneous (SC) injection
Isatuximab	DRUG	Administered per the protocol
Fianlimab	DRUG	Administered per the protocol
Cemiplimab	DRUG	Administered per the protocol
Nirogacestat	DRUG	Administered per the protocol
Cevostamab	DRUG	Administered per the protocol

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Eligibility Criteria

Age Range18 Years to N/A

SexALL

Healthy VolunteersNo

Study Sites20

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 StatesJapanSouth KoreaUnited KingdomAustraliaBrazilChileTaiwanBelgiumCanadaFranceGermanyIsraelItalyNetherlandsPolandSingaporeSpainIrelandGreece

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Recent Changes (Last 90 Days)

LOWOct 8, 2026NCT07222761lastUpdatePostDate: changed

LOWOct 7, 2026NCT05730036lastUpdatePostDate: changed

LOWOct 7, 2026NCT07393282lastUpdatePostDate: changed

LOWOct 7, 2026NCT05730036lastUpdatePostDate: changed

LOWOct 7, 2026NCT07393282lastUpdatePostDate: changed

LOWSep 30, 2026NCT05730036lastUpdatePostDate: changed

LOWSep 29, 2026NCT07222761lastUpdatePostDate: changed

LOWSep 25, 2026NCT07393282lastUpdatePostDate: changed

LOWSep 16, 2026NCT07393282lastUpdatePostDate: changed

LOWSep 15, 2026NCT07222761lastUpdatePostDate: changed

LOWSep 11, 2026NCT07455851lastUpdatePostDate: changed

Frequently asked questions about linvoseltamab

What is linvoseltamab?

Linvoseltamab is an investigational monoclonal antibody being developed by Regeneron Pharmaceuticals, Inc. (ticker REGN). It is being studied in multiple myeloma and related plasma cell conditions, including relapsed and/or refractory multiple myeloma, high risk smoldering multiple myeloma, monoclonal gammopathy of undetermined significance, and food allergy. It remains in clinical development and is not described as approved.

What does linvoseltamab target?

Linvoseltamab targets CD3 and BCMA. It is a bispecific monoclonal antibody designed to bind BCMA on plasma cells and CD3 on T cells, bringing the two cell types together. This mechanism is being investigated across plasma cell disorders such as relapsed and/or refractory multiple myeloma and high risk smoldering multiple myeloma.

Who makes linvoseltamab?

Linvoseltamab is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is running the clinical program, including a Phase 1 combination study of REGN17372 with linvoseltamab and several later-stage studies in multiple myeloma and smoldering multiple myeloma.

What phase is linvoseltamab in?

Linvoseltamab is in clinical development, with studies spanning Phase 1 through Phase 3. The program includes a Phase 1 combination trial, a Phase 2 maintenance study, and two Phase 3 trials. It is investigational and has not been described as approved by the FDA for any indication.

What clinical trials is linvoseltamab in?

Linvoseltamab is being studied in five trials, three of which are recruiting. These include NCT07455851, a Phase 1 combination study with REGN17372 in relapsed/refractory multiple myeloma; NCT07393282, a Phase 3 comparison with daratumumab in high risk smoldering multiple myeloma; NCT07222761, a Phase 3 study in relapsed/refractory multiple myeloma; and NCT06910124, a Phase 2 maintenance study with lenalidomide.

What is linvoseltamab used for in multiple myeloma?

Linvoseltamab is being investigated for relapsed and/or refractory multiple myeloma, including as monotherapy and in combination with carfilzomib or REGN17372, and for high risk smoldering multiple myeloma. It is also being studied in a Phase 2 maintenance setting with lenalidomide for multiple myeloma. These uses remain investigational.

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linvoseltamab

linvoseltamab development status

linvoseltamab target and mechanism

Success Probability

Market & Valuation

Trial Design

FDA Designations

linvoseltamab clinical trials

Study Endpoints

Primary Endpoints

Secondary Endpoints

Study Design & Arms

Treatment Arms

Interventions

Eligibility Criteria

Recent Changes (Last 90 Days)

Frequently asked questions about linvoseltamab

What is linvoseltamab?

What does linvoseltamab target?

Who makes linvoseltamab?

What phase is linvoseltamab in?

What clinical trials is linvoseltamab in?

What is linvoseltamab used for in multiple myeloma?

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