OncoMatch/Clinical Trials/NCT06994676
A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Is NCT06994676 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CBX-250 for high-risk myelodysplastic syndrome.
Treatment: CBX-250 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Biomarker criteria
Required: HLA-A A*02:01 allele positivity
Historical documented evidence of HLA-A*02:01 allele positivity
Prior therapy
Must have received: hypomethylating agent (decitabine, azacitidine) — R/R HR-MDS, very high risk MDS, or R/R CMML
resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine)
Cannot have received: CTSG targeted therapy
Previous CTSG targeted therapy or treatment with any pMHC T-cell engager
Cannot have received: pMHC T-cell engager
Previous CTSG targeted therapy or treatment with any pMHC T-cell engager
Lab requirements
Blood counts
White blood cells must be below 25,000/µL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
Kidney function
Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 based on local institutional practice for age-appropriate determination (eg, Schwartz formula for pediatric participants or Cockcroft-Gault formula for adults).
Liver function
Total bilirubin <1.5 × ULN for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions. ALT and AST <3 × ULN (unless attributed to leukemic involvement with discussion with the Study Responsible Physician).
Cardiac function
QTc using Fridericia's correction (QTcF) >480 msec [excluded]. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class >II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack [excluded].
Adequate Organ Function Requirements within 10 Days of Treatment Initiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- Stanford Medical Center · Palo Alto, California
- Moffitt Cancer Center · Tampa, Florida
- Northwestern Medicine · Chicago, Illinois
- Dana Farber Cancer Institute · Boston, Massachusetts
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