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# Clinical Hold on Regeneron Odronextamab Trials
- URL: https://www.fdaweb.com/clinical-hold-on-regeneron-odronextamab-trials/
- Published: 2020-12-15T12:00:00.000Z
- Updated: 2026-09-14T16:40:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148303

In response to an FDA clinical hold, Regeneron says it is pausing new enrollment of patients with B-cell non-Hodgkin lymphomas (B-NHL) in trials for odronextamab. The company [says](https://investor.regeneron.com/static-files/690eeaf2-643e-44eb-9c3f-baad97eb9703?ref=fdaweb.com) FDA asked that it amend the trial protocols to further reduce the incidence of ≥Grade 3 cytokine release syndrome during step-up dosing.

Regeneron says it plans to submit a protocol amendment to FDA with the goal of resuming patient enrollment early in the first quarter of 2021.

The two trials that were currently enrolling patients were a Phase 1 monotherapy trial in B-NHL and chronic lymphocytic leukemia and a Phase 2 monotherapy trial in several B-NHL subtypes.