A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma
← catalyst calendarNCT06669247 · readout in 2,641 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
186estimated
Sites
9
Countries
Australia, United Kingdom
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-12-11 | actual | When the study began enrolling |
| Primary completion | 2033-11-11 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2035-11-01 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed/Refractory Multiple Myeloma
Interventions
- Drug: Linvoseltamab — also filed as REGN5458
- Drug: REGN7945+Linvoseltamab
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicities (DLTs) from the first dose of REGN7945 in combination with linvoseltamab
measured Up to 21 days
Incidence of treatment emergent adverse events (TEAEs) during the treatment period with REGN7945 in combination with linvoseltamab
measured Up to 5 years
Severity of TEAEs during the treatment period with REGN7945 in combination with linvoseltamab
measured Up to 5 years
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
measured Within 12 weeks of starting cycle 1
VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
measured Within 12 weeks of starting cycle 1
Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination therapy
measured Within 12 weeks of starting cycle 1
PR or better as determined by the investigator using the IMWG response criteria in patients receiving linvoseltamab monotherapy
measured Within 12 weeks of starting cycle 1
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