NCT03604692

A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD

A Phase 1/2, Open-Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Activity, and Efficacy of SNDX- 6352 in Subjects With Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Prior Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).

Detailed description

This is a dose escalation and dose expansion study in participants with active cGVHD who have received at least 2 lines of prior therapy.

Conditions

• Chronic Graft-versus-host-disease

Interventions

Type	Name	Description
DRUG	axatilimab	axatilimab is a high affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor derived macrophages that mediate the disease processes involved in cGVHD.

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-08-12
• Completion: 2024-10-18
• First posted: 2018-07-27
• Last updated: 2025-09-15
• Results posted: 2024-11-27

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study