Actively Recruiting
A Study 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
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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, or aged 12 years or older for backfill cohorts without curative treatment options
- Histological confirmation of relapsed or refractory AML, HR-MDS, very high risk MDS, or CMML resistant to 4-6 cycles of hypomethylating agents
- White blood cell count below 25,000/µL at enrollment; cytoreduction allowed before enrollment
- Documented HLA-A*02:01 allele positivity
- ECOG performance status 0-1 if aged 18 years or older; Karnofsky or Lansky performance score of 70 or higher if younger
- Prior treatment toxicities resolved to Grade 1 or less, except alopecia up to Grade 2
- Specified waiting periods after radiation, stem cell transplant, immunotherapy, anti-leukemia therapy, growth factors, biologics, and steroids
- Adequate kidney and liver function as defined by specific laboratory values
- Willingness to use 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 unless cleared by lumbar puncture
- Known HIV infection
- Active hepatitis B or C infection unless cleared
- Pregnant or breastfeeding women
- Certain recent cardiac diseases or abnormal QTc interval exceeding 480 msec
- Active graft-versus-host disease requiring systemic immunosuppressive treatment
- Concurrent malignancy within 2 years except certain treated skin or in situ cancers
- Any condition or therapy that might interfere with study participation or results per investigator
- Use of other anti-leukemic therapies besides CBX-250, with some exceptions
- Participation in other investigational drug studies within 14 days or 5 half-lives
- Systemic treatment to prevent graft-versus-host disease, except topical treatments
- Known allergy or sensitivity to CBX-250 or its ingredients
AI-Screening
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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
CONTACT
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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