Asset profile

REGN5459

Multispecific antibody

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Weakdesign only

Evidence outlook · no controlled comparison

NCT04083534 · Relapsed Multiple Myeloma, Refractory Multiple Myeloma

The lead study is single-arm or otherwise uncontrolled, so it produced no formal comparison against a control. This tier describes the design, not an outcome.

NCT04083534: This early-stage study gave REGN5459 to 43 people with relapsed or refractory multiple myeloma across a range of doses, with no randomisation, no masking and no comparison group. Its primary measure was dose-limiting toxicity: one such event occurred, a grade 3 drop in blood oxygen at the highest 900 mg dose, the maximum tolerated dose was not reached, and 480 mg was chosen for later study. A study of this shape shows which doses are tolerated, not whether the drug works better than an alternative.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

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Competitive landscape

71 competitors in this universe: 10 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 61 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
REGN5459: this drugPhase 1/2Multispecific antibodyBCMA x CD3
ElranatamabApprovedMultispecific antibodyBCMA x CD3
LinvoseltamabApprovedMultispecific antibodyBCMA x CD3
TeclistamabApprovedMultispecific antibodyBCMA x CD3
BCD-248Phase 3Multispecific antibodyBCMA x CD3
CM336Phase 3Multispecific antibodyBCMA x CD3
EtentamigPhase 3Multispecific antibodyBCMA x CD3
F182112Phase 3Multispecific antibodyBCMA x CD3
GR1803Phase 3Multispecific antibodyBCMA x CD3
TQB2934Phase 3Multispecific antibodyBCMA x CD3
YKST02Phase 2Multispecific antibodyBCMA x CD3
CizutamigPhase 1Multispecific antibodyBCMA x CD3
Belantamab MafodotinApprovedAntibody–drug conjugateBCMA
BortezomibApprovedSmall moleculeProteasome
CarfilzomibApprovedSmall moleculeProteasome
Ciltacabtagene AutoleucelApprovedCell therapyBCMA

…and 56 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Compare head-to-head

4 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.

Upcoming events

(2 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
November 2027 (1)
Phase 1/2Chronic Kidney Disease (CKD)Active not recruiting
Est. primary completion 2027-11-22 · NCT05092347 · CT.gov ↗
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2029 (1)
September 2029 (1)
Phase 1Lupus Nephritis (LN)Recruiting
Est. primary completion 2029-09-10 · NCT06975787 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 1/2 (2)
Phase 1 (1)