REGN17372 for Relapsed/refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol"}
• {"criterion_text":"- ECOG performance status score ≤1"}
• {"criterion_text":"- Participants must have measurable disease for response assessment as described in the protocol"}
• {"criterion_text":"- Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol"}

Exclusion criteria

• {"criterion_text":"- Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol"}
• {"criterion_text":"- Participants who have known MM brain lesions or CNS involvement"}
• {"criterion_text":"- Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening"}
• {"criterion_text":"- Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)"}
• {"criterion_text":"- Note: Other protocol defined inclusion/exclusion criteria apply"}

Primary endpoints

• {"endpoint_text":"- Phase 1: Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab","definition_or_measurement_approach":"Occurrence of Dose Limiting Toxicities (DLTs) from the first dose"}
• {"endpoint_text":"- Phase 1: Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab","definition_or_measurement_approach":"Occurrence of TEAEs associated with REGN17372 in combination with linvoseltamab"}
• {"endpoint_text":"- Phase 1: Severity of TEAEs associated with REGN17372 in combination with linvoseltamab","definition_or_measurement_approach":"Severity grading of TEAEs associated with REGN17372 in combination with linvoseltamab"}
• {"endpoint_text":"- Phase 2: 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","definition_or_measurement_approach":"Response assessed by investigator using IMWG response criteria; endpoint = VGPR or better in patients receiving combination study drugs"}
• {"endpoint_text":"- Phase 2: VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy","definition_or_measurement_approach":"Response assessed by investigator using IMWG response criteria; endpoint = VGPR or better in patients receiving linvoseltamab monotherapy"}
• {"endpoint_text":"- Phase 2: Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs","definition_or_measurement_approach":"Response assessed by investigator using IMWG response criteria; endpoint = PR or better in patients receiving combination study drugs"}
• {"endpoint_text":"- Phase 2: PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy","definition_or_measurement_approach":"Response assessed by investigator using IMWG response criteria; endpoint = PR or better in patients receiving linvoseltamab monotherapy"}

Secondary endpoints

• {"endpoint_text":"- Phase 1 and Phase 2: Concentrations of REGN17372 in serum","definition_or_measurement_approach":"Serum concentrations of REGN17372 (pharmacokinetics)"}
• {"endpoint_text":"- Phase 1 and Phase 2: Concentrations of linvoseltamab in serum","definition_or_measurement_approach":"Serum concentrations of linvoseltamab (pharmacokinetics)"}
• {"endpoint_text":"- Phase 1 and Phase 2: Occurrence of Anti-Drug Antibodies (ADA) to REGN17372","definition_or_measurement_approach":"Incidence of ADA to REGN17372"}
• {"endpoint_text":"- Phase 1 and Phase 2: Magnitude of ADA to REGN17372","definition_or_measurement_approach":"Magnitude (titres/levels) of ADA to REGN17372"}
• {"endpoint_text":"- Phase 1 and Phase 2: Incidence of ADA to linvoseltamab","definition_or_measurement_approach":"Incidence of ADA to linvoseltamab"}
• {"endpoint_text":"- Phase 1 and Phase 2: Magnitude of ADA to linvoseltamab","definition_or_measurement_approach":"Magnitude (titres/levels) of ADA to linvoseltamab"}
• {"endpoint_text":"- Phase 1 and Phase 2: Objective Response Rate (ORR) as assessed by IMWG response criteria as determined by the investigator","definition_or_measurement_approach":"ORR assessed by investigator using IMWG criteria"}
• {"endpoint_text":"- Phase 1 and Phase 2: Complete response (CR) as assessed by IMWG response criteria as determined by the investigator","definition_or_measurement_approach":"CR assessed by investigator using IMWG criteria"}
• {"endpoint_text":"- Phase 1 and Phase 2: VGPR as assessed by IMWG response criteria, as determined by the investigator","definition_or_measurement_approach":"VGPR assessed by investigator using IMWG criteria"}
• {"endpoint_text":"- Phase 1 and Phase 2: Duration of Response (DOR) as assessed by IMWG criteria as determined by the investigator","definition_or_measurement_approach":"DOR assessed per IMWG criteria"}
• {"endpoint_text":"- Phase 1 and Phase 2: Progression Free Survival (PFS) as assessed by IMWG criteria as determined by the investigator","definition_or_measurement_approach":"PFS assessed per IMWG criteria"}
• {"endpoint_text":"- Phase 1 and Phase 2: Minimal Residual Disease (MRD) negative status (at 10^-5) in participants in CR or better","definition_or_measurement_approach":"MRD negative status assessed at 10^-5 in participants with CR or better"}
• {"endpoint_text":"- Phase 1 and Phase 2: Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (time to death from any cause)"}
• {"endpoint_text":"- Phase 1: ORR as assessed using the IMWG response criteria as determined by the investigator in patients receiving combination study drugs","definition_or_measurement_approach":"ORR (phase 1) assessed by investigator using IMWG criteria in patients on combination therapy"}
• {"endpoint_text":"- Phase 1:VGPR assessed using IMWG criteria as determined by the investigator in patients receiving combination study drugs","definition_or_measurement_approach":"VGPR (phase 1) assessed by investigator using IMWG criteria in patients on combination therapy"}
• {"endpoint_text":"- Phase 2: Incidence of TEAEs","definition_or_measurement_approach":"Incidence of treatment-emergent adverse events"}
• {"endpoint_text":"- Phase 2: Severity of TEAEs","definition_or_measurement_approach":"Severity (grading) of treatment-emergent adverse events"}
• {"endpoint_text":"- Phase 2: Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Global Health Status / Quality of Life (GHS/QoL)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 GHS/QoL score"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-C30 Physical Functioning (PF)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 Physical Functioning score"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-C30 Role Functioning (RF)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 Role Functioning score"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-C30 pain","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 pain score"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-C30 fatigue","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-C30 fatigue score"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-C30 GHS/QoL"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-C30 PF","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-C30 Physical Functioning"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-C30 RF","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-C30 Role Functioning"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-C30 pain","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-C30 pain"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-C30 fatigue","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-C30 fatigue"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-C30 GHS/QoL","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-C30 GHS/QoL"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-C30 PF","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-C30 Physical Functioning"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-C30 RF","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-C30 Role Functioning"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-C30 pain","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-C30 pain"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-C30 fatigue","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-C30 fatigue"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-Multiple Myeloma Module (MY20) Disease Symptoms (DS)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-MY20 Disease Symptoms"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 DS","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-MY20 Disease Symptoms"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-MY20 DS","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-MY20 Disease Symptoms"}
• {"endpoint_text":"- Phase 2: Change from baseline in EORTC QLQ-MY20 Treatment Side Effects (TSE)","definition_or_measurement_approach":"Change from baseline in EORTC QLQ-MY20 Treatment Side Effects"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EORTC QLQ-MY20 TSE","definition_or_measurement_approach":"Time to definitive deterioration in EORTC QLQ-MY20 Treatment Side Effects"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EORTC QLQ-MY20 TSE","definition_or_measurement_approach":"Time to first improvement in EORTC QLQ-MY20 Treatment Side Effects"}
• {"endpoint_text":"- Phase 2: Change from baseline in EuroQoL-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (EQ-5D-5L VAS)","definition_or_measurement_approach":"Change from baseline in EQ-5D-5L VAS"}
• {"endpoint_text":"- Phase 2: Time to definitive deterioration in EQ-5D-5L VAS","definition_or_measurement_approach":"Time to definitive deterioration in EQ-5D-5L VAS"}
• {"endpoint_text":"- Phase 2: Time to first improvement in EQ-5D-5L VAS","definition_or_measurement_approach":"Time to first improvement in EQ-5D-5L VAS"}
• {"endpoint_text":"- Phase 2: Patient-reported overall impact of treatment toxicity measured by Functional Assessment of Cancer Therapy (FACIT) Item GP5","definition_or_measurement_approach":"Patient-reported overall impact of treatment toxicity measured by FACIT Item GP5"}
• {"endpoint_text":"- Phase 2: Patient-reported tolerability as measured by the Patient Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE)","definition_or_measurement_approach":"Patient-reported tolerability measured by PRO-CTCAE"}

Greece

Earliest CTIS Part Ii Submission Date

14-01-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

98

Number Of Sites

2

Number Of Participants

26

Primary sponsor

Full Name

Regeneron Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Holdings Inc.

Responsibilities

Study Data Manager

Name

Icon (Lr) Limited

Responsibilities

Project Manager Project management (e.g. Monitoring, regulatory, SUSAR reporting)

Name

PRA Hellas CRO A.E.

Responsibilities

legal entity in Greece

Name

Perceptive Eclinical Limited

Responsibilities

Senior Project Manager/ Central Imaging

Third parties

• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"Sr Strategic Alliance and Business Development Manager","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Holdings Inc.","duties_or_roles":"Study Data Manager","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Project Manager Project management (e.g. Monitoring, regulatory, SUSAR reporting)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"Clinical Distribution Project Manager","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Portfolio Manager","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"legal entity in Greece","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Senior Project Manager/ Central Imaging","organisation_type":"Pharmaceutical company"}