New drug GL-0719 enters first human trials for rare blood disorder

NCT ID NCT05318534

Recruiting now Disease control Sponsor: Gliknik Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called GL-0719 in healthy volunteers and people with cold agglutinin disease, a rare condition where cold temperatures cause the immune system to destroy red blood cells. The study aims to check safety, how the drug moves through the body, and whether it shows any signs of working. It involves 70 participants and is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: GL-0719
What this could lead to: If successful, this could point toward a new treatment option for cold agglutinin disease, a rare condition where the immune system attacks red blood cells.
What could go wrong: This is a very early Phase 1 trial with only 70 participants, focused mainly on safety. It is too soon to know if GL-0719 will work or be safe for wider use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cold agglutinin disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FIRST IN MAN STUDY TO EVALUATE INITIAL SAFETY

Contacts and locations

Locations

Fortrea Clinical Research Unit Ltd
RECRUITING

Leeds, LS2 9LH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.