NCT06994676

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Crossbow Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.

Conditions

• High-risk Myelodysplastic Syndrome
• Chronic Myelomonocytic Leukemia (CMML)
• AML - Acute Myeloid Leukemia
• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	CBX-250	subcutaneous CBX-250

Timeline

• Start date: 2025-07-16
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2025-05-29
• Last updated: 2026-03-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study