RecruitingPhase 1NCT06994676

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


Sponsor

Crossbow Therapeutics, Inc.

Enrollment

72 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called CBX-250 for people with blood cancers — specifically acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) — that have come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older (or as young as 12 in certain cases) with relapsed or treatment-resistant AML, MDS, or CMML - Your cancer has not responded to standard treatments, including stem cell transplant - You carry a specific genetic marker called HLA-A*02:01 - Your heart, liver, and kidneys are functioning well enough to handle treatment - You have recovered from most side effects of your last treatment **You may NOT be eligible if...** - You have active HIV, hepatitis B, or hepatitis C - You have active cancer in your brain or spinal fluid - You have serious heart problems (e.g., recent heart attack or severe heart failure) - You have active graft-versus-host disease requiring immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBX-250

subcutaneous CBX-250


Locations(11)

City of Hope

Duarte, California, United States

Stanford Medical Center

Palo Alto, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern Medicine

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University in St. Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Sarah Cannon Cancer Institute

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06994676


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