CBX-250 for Acute Myeloid Leukemia

(CROSSCHECK-001 Trial)

Recruiting at 1 trial location

Overseen By Rachel Ghiraldi

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Crossbow Therapeutics, Inc.

Must not be taking: Anti-leukemic therapy

Disqualifiers: HIV, Hepatitis B, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS and CMML. 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.

Who Is on the Research Team?

Briggs Morrison, MD

Principal Investigator

Crossbow Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals aged ≥12 with relapsed/refractory Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia who have not responded to certain treatments. Participants must have a specific HLA type and white blood cell counts below a set threshold.

Inclusion Criteria

My MDS is high-risk and hasn't responded to 4-6 cycles of specific treatments.

I have been tested positive for the HLA-A*02:01 gene.

My daily activity is not severely limited.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Priming Phase

Participants receive a priming dose of CBX-250 over 7 days

1 week

Target Phase

Participants receive CBX-250 on a fixed step-up dosing schedule over 28 days

4 weeks

Subsequent Treatment Cycles

Participants continue CBX-250 in 28-day cycles until progressive disease or unacceptable toxicity

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• CBX-250

Trial Overview CBX-250 is being tested in this Phase 1 trial. It's given as an under-the-skin injection in cycles of 28 days, starting with a priming phase followed by a target phase. Patients continue until disease progression or unacceptable side effects occur.

How Is the Trial Designed?

Group I: CBX-250 Experimental Treatment 1 Intervention

subcutaneous CBX-250

Who Is Running the Clinical Trial?

Crossbow Therapeutics, Inc.

Lead Sponsor