CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
axatilimabdrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age ≥6 years at time of informed consent
  • ✓Allogeneic HSCT recipient with cGVHD requiring systemic immune suppression
  • ✓Active cGVHD with ≥2 prior therapy lines; patients ≥18 with erythematous rash >25% BSA or NIH mouth score >4 must have received prior ibrutinib
  • ✓Karnofsky ≥60 if age ≥16 years; Lansky ≥60 if age <16 years
Key exclusion· 7
  • ✕Acute GVHD without cGVHD manifestations
  • ✕Evidence of relapse of underlying cancer or post-transplant lymphoproliferative disease at screening
  • ✕Severe illness, uncontrolled infection, or other conditions unsuitable for study per investigator
  • ✕Known HIV, active HCV, or active HBV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03604692
NCT03604692Phase 2Completed
CompareCT.gov

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

Syndax Pharmaceuticals·interventional·Posted Jul 27, 2018·Updated Sep 15, 2025

In Brief

A Phase 2 clinical trial evaluating axatilimab for Chronic Graft-versus-host-disease. Completed, enrolled 41 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Graft-versus-host-disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartNov 1, 2018
Primary CompletionAug 12, 2022
Study CompletionOct 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.9 years ago

Interventions

axatilimabdrug

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.