Loading clinical trials...

RECRUITINGPHASE1

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

NCT06994676•Crossbow Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•Age
•1. Dose Escalation: Male or female participants aged ≥18 years.
•2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available.
•Diagnosis \& Disease Characteristics
•3. Participants with histological confirmation of advanced hematologic malignancy including:
•1. R/R AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \[Dohner 2022\]; after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible.
•2. R/R HR-MDS or very high risk MDS as per the Revised International Prognostic Scoring System (IPSS-R; Greenberg 2012) or Molecular International Prognostic Scoring System (IPPS-M, Bernard 2022) who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).
•3. R/R CMML who are resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).
•4. White blood cells must be below 25,000/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
+25 more criteria

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•Diagnosis
•1. Previous CTSG targeted therapy or treatment with any pMHC T-cell engager.
•2. Isolated extramedullary relapse.
•3. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy).
•Infection
•4. Known HIV infection.
•5. Active hepatitis B infection (participants with documented clearance following treatment are allowed).
•6. Active hepatitis C infection (participants with documented clearance following treatment are allowed).
•Pregnancy and Breastfeeding
+14 more criteria

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

Key Dates

Start Date

July 16, 2025

Primary Completion Date

January 1, 2027

Completion Date

June 1, 2027

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

High-risk Myelodysplastic SyndromeChronic Myelomonocytic Leukemia (CMML)AML - Acute Myeloid LeukemiaChronic Myeloid Leukemia

Interventions

CBX-250

DRUG

Contacts

Rachel Ghiraldi

CONTACT

857-301-6432 rachel.ghiraldi@crossbowtx.com

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

View study

RECRUITINGPHASE1/PHASE2

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

NCT07128381

Myelofibrosis (MF)Chronic Myelomonocytic Leukemia (CMML)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX

Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN