NCT05423691

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

Phase Ib, Open-label Study of Add on Therapy With CK0804 in Participants With Myelofibrosis, With Suboptimal Response to Ruxolitinib

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Cellenkos, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib

Detailed description

1. Safety Run-in The study will employ a 3+3+3 design to assess the safety and tolerability of the treatment based on treatment-limiting toxicities (TLTs) occurring up to 1 Cycle (28 days) after the first infusion. 2. Expansion After a total of 9 participants completed 28 days and are evaluated for tolerability in the safety run-in phase, additional participants may be included in the expansion cohort in order to have approximately 24 evaluable myelofibrosis

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	CK0804	CK0804 is a cryopreserved, allogeneic T-regulatory cell product that is manipulated to traffic to the bone marrow.

Timeline

• Start date: 2022-12-27
• Primary completion: 2026-04-30
• Completion: 2026-12-30
• First posted: 2022-06-21
• Last updated: 2025-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study