RecruitingPhase 1Phase 2NCT07069699

Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene

Phase 1b/2 Trial of Pidnarulex in MYC Aberrant Lymphoma


Sponsor

National Cancer Institute (NCI)

Enrollment

50 participants

Start Date

Oct 13, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II trial tests the safety, side effects, best dose and how well giving CX-5461 works for the treatment of patients with B-cell non-Hodgkin lymphoma. CX-5461 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CX-5461 may be safe, tolerable and/or effective in treating patients with B-cell non-Hodgkin lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a drug called CX-5461 (pidnarulex) in adults with aggressive B-cell lymphomas — specifically those with certain changes in a gene called MYC — whose cancer has come back or stopped responding to at least two prior treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with double-expressor lymphoma, high-grade B-cell lymphoma with MYC and BCL2/BCL6 changes, or Burkitt lymphoma - You have received at least two prior treatments for DLBCL (or at least one for Burkitt lymphoma) and no standard treatment options remain effective - Your blood counts and organ function are in acceptable range - If HIV-positive, your viral load must be undetectable on effective treatment **You may NOT be eligible if...** - You have cancer spread to the brain (CNS lymphoma) - You have a heart rhythm problem causing prolonged QT interval - You are taking strong CYP3A4-interacting medications that cannot be stopped - You are pregnant or breastfeeding - You have uncontrolled serious illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo CSF and blood sample collection

PROCEDUREComputed Tomography

Undergo PET/CT scan

PROCEDURELumbar Puncture

Undergo lumbar puncture

DRUGPidnarulex

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT scan


Locations(4)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07069699


Related Trials