Actively Recruiting
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
Led by Crossbow Therapeutics, Inc. · Updated on 2026-03-16
72
Participants Needed
11
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CBX-250, a drug administered under study, in participants aged 12 years and older with relapsed or refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS), chronic myelomonocytic leukemia (CMML), and chronic myeloid leukemia (CML). This is a Phase 1, open-label, dose-escalation trial designed to study the safety, tolerability, and clinical activity of CBX-250. The study is led by Crossbow Therapeutics, Inc. and focuses on participants with advanced blood cancers who have limited treatment options. CBX-250 is given by subcutaneous injection in 28-day cycles. The first cycle includes a 7-day priming phase followed by a 28-day target phase. Participants will receive CBX-250 repeatedly until the disease progresses or unacceptable side effects occur. Dose escalation is part of the study to find the recommended Phase 2 dose or maximum tolerated dose. The study does not include placebo or blinding. Participants will undergo regular assessments including safety monitoring, blood tests, and evaluations of disease response as measured by criteria such as overall response rate and remission rates. The study also tracks pharmacokinetics and immune responses up to about one year, with longer-term follow-up for event-free survival and overall survival measures. The total study duration is approximately 24 months, with ongoing safety and clinical activity evaluations throughout.
CONDITIONS
Brief Title
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older for dose escalation.
- Male or female participants aged 12 years or older for backfill cohorts without curative treatment options.
- Histological confirmation of relapsed or refractory AML, HR-MDS, CMML, or CML.
- White blood cells below 25,000/µL at enrollment; cytoreduction allowed prior.
- Documented HLA-A*02:01 allele positivity.
- ECOG performance status 0-1 if aged 18 years or older; Karnofsky or Lansky score of 70 or higher if younger.
- Prior treatment toxicities resolved to Grade 1 or less, except Grade 2 alopecia.
- Specific timing requirements met for prior radiation, stem cell infusion, immunotherapy, anti-leukemia therapy, hematopoietic growth factors, biologics, and steroid use.
- Adequate kidney and liver function within 10 days before treatment.
- Willingness to use effective contraception if of childbearing potential.
- Ability to provide written informed consent and follow study instructions.
You will not qualify if you...
- Prior treatment with CTSG targeted therapy or any pMHC T-cell engager.
- Isolated extramedullary relapse.
- Active central nervous system disease without negative lumbar puncture after chemotherapy.
- Known HIV infection.
- Active hepatitis B or C infection unless documented clearance.
- Pregnant or nursing women without confirmed negative pregnancy tests.
- Recent serious cardiac events or uncontrolled heart conditions.
- Active graft-versus-host disease requiring systemic immunosuppressive treatment.
- Concurrent malignancies within the past 2 years except certain treated skin or in situ cancers.
- Conditions or therapies that may interfere with study participation or results.
- Use of other anti-leukemic therapies except specific allowed treatments.
- Participation in another investigational study with investigational agents within 14 days or 5 half-lives.
- Use of systemic treatments to prevent graft-versus-host disease except topical treatments.
- Known allergies or sensitivities to CBX-250 or its components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until the end of study (approximately 24 months)
Participants receive subcutaneous CBX-250 to evaluate safety, tolerability, and clinical activity.
Visits occur according to dosing and safety monitoring schedules
Duration - Up to 3 years
Participants are monitored for outcomes such as response rates and survival after treatment ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 11 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Stanford Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
9
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Rachel Ghiraldi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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