Phase 1 Study of CBX-250 Given by Injection for Patients Aged 12 and Older With Relapsed or Refractory Myeloid Leukemias

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.

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