A Phase I/II clinical trial of Regeneron Pharmaceuticals' REGN7041, an investigational anti-CD3 monoclonal antibody for non-infectious uveitis, has been terminated after enrolling one participant following a safety event. Regeneron confirmed to Fierce Biotech that it voluntarily ended the TITAN study after a review of the event prompted an updated risk-benefit assessment of the treatment. The company said its investigation had not identified the underlying cause of the event.
The TITAN trial (NCT07218770) was a first-in-human, open-label dose-escalation study evaluating REGN7041 in adults with active non-infectious uveitis affecting the posterior segment. The study was designed to progress from single ascending doses into multiple ascending doses, with safety and tolerability as its primary objective. ClinicalTrials.gov now lists actual enrollment of one participant. Regeneron has not disclosed the nature or severity of the adverse event or whether it was considered related to REGN7041.
REGN7041 targets CD3, a component of the T-cell receptor complex, and was being developed as an immunomodulatory approach to non-infectious uveitis, a group of inflammatory eye diseases that can cause vision loss. Regeneron listed the candidate in Phase I development for uveitis in its January 2026 corporate pipeline.
The termination brings clinical development to an unusually early halt, with TITAN ending before progressing through its planned dose-escalation program. No other active clinical studies of REGN7041 were identified, and Regeneron has not announced further development plans for the candidate.
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