Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-02 @ 1:17 PM
Study NCT ID:
NCT03604692
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2018-07-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
Sponsor:
Syndax Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: