Testing Pidnarulex for Lymphoma with MYC Gene Changes
This study is testing a drug called Pidnarulex (also known as CX-5461) for people with certain types of aggressive B-cell non-Hodgkin lymphoma, including Burkitt Lymphoma, Double-Expressor Lymphoma, or High Grade B-Cell Lymphoma with specific MYC and BCL2 and/or BCL6 gene changes. You must have received at least one or two prior treatments. Researchers want to find out if Pidnarulex is safe, what the best dose is, and how well it works. Pidnarulex may work by stopping cancer cells from growing by blocking enzymes they need. The study aims to see if Pidnarulex can shrink tumors and improve outcomes. About 50 people are expected to join.
- Study design
- This is a Phase 1/2 interventional study, meaning it tests safety and then effectiveness. It plans to enroll 50 participants.
- What's involved
- You would receive Pidnarulex intravenously (through a vein) on specific days. You would also have procedures like lumbar punctures (spinal tap), PET/CT scans, tumor biopsies, and blood draws throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 days after your last dose. Researchers will also track other outcomes for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07069699
Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~50 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyLumbar PuncturePidnarulexPositron Emission Tomography
At a glance
Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (Phase 1)
Measured over Up to 30 days after last dose of study treatment
+4 more outcomes measured
Conditions
Where it's being run
8 sites across 4 statesKansas4
California2
Oklahoma1
Pennsylvania1
Study leadership
- Sami Ibrahimi · PRINCIPAL_INVESTIGATOR · Yale University Cancer Center LAO
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have one of the following subtypes of aggressive B-cell non-Hodgkin lymphomas: double-expressor lymphoma (DEL), high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement, or Burkitt lymphoma (BL). Eligible patients must have received at least two prior lines of treatment for diffuse large B-cell lymphoma (DLBCL) or at least one prior line of therapy for Burkitt Lymphoma and must have disease for which no standard curative or palliative treatment options exist or remain effective (Quin et al., 2016)
Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of CX-5461 (Pidnarulex) in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). ECOG 3 is allowed if directly related to lymphoma per treating provider
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 50,000/mcL
Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)
Patients with documented Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is within normal limits
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional upper limit of normal (ULN)
Glomerular filtration rate (GFR) ≥ 60 mL/min/, calculated by multiplying the estimated (e)GFR (mL/min/1.73 m\^2) by the individual's body surface area (BSA, calculated using an accepted formula) and dividing by 1.73 m\^2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
Patients with cytopenia related to abnormal bone marrow function in the setting of bone marrow involvement with lymphoma or post chimeric antigen receptor (CAR) T-cell are allowed to enroll if deemed safe by treating provider
Patients without clinical evidence of central nervous system (CNS) lymphoma
The effects of CX-5461 (Pidnarulex) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CX-5461 (Pidnarulex) and for 6 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (Pidnarulex) administration. Women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 6 months after completion of the last dose CX-5461 (Pidnarulex)
Willingness to provide blood and biopsy samples for research purposes
Ability to understand and the willingness to sign a written informed consent document
Exclusion
Patients must have recovered from clinically significant adverse events (AEs) of their most recent cancer immunotherapy to grade 1 or less (with the exception for alopecia or lymphopenia)
Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (Pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. For medications or substances not listed, or in cases of uncertainty, the Principal Investigator may consult with a medical expert or a pharmacologist to make an informed decision regarding eligibility
Patients with a baseline corrected QT (QTc) interval \> 480 msec
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (Pidnarulex)
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because CX-5461 (Pidnarulex) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CX-5461 (Pidnarulex), breastfeeding should be discontinued if the mother is treated with CX-5461 (Pidnarulex)
What this trial measures
- Incidence of adverse events (Phase 1)Up to 30 days after last dose of study treatment
Assessed by the Common Terminology Criteria for Adverse Events version 5. Safety will be summarized overall, by actual dose level in Phase 1b.
- Recommended phase 2 dose (RP2D) (Phase 1)Up to 5 years
- Pharmacokinetic (PK) levels (Phase 1)At cycle (C) 1 day (D) 8 at pre-dose, end of infusion, and 2 hours (hrs) post-dose; on C1D9 at 24 hrs post C1D8 infusion; on C1D10 at 48 hrs post C1D8 infusion; on C1D11 at 72 hrs post C1D8 infusion; and on C1D15 at 167 hrs post C1D8 infusion
Assessed using Liquid Chromatography Mass Spectrometry (LC-MS).
- Gene expression (Phase 1)At baseline, C1D9 or C1D10 (within 24-48 hrs of C1D8 dosing),and at progression
Assessed by ribonucleic acid sequencing complemented by whole exome sequencing using an average absolute log2 fold change relative to baseline with a significance threshold of p \< 0.05.
- Overall response rate (Phase 2)Up to 5 years
Assessed using standard radiographic criteria according to Lugano criteria. Phase 2 results will be reported at the RP2D.