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

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07069699
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Burkitt Lymphoma
  • Double-Expressor Lymphoma
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo CSF and blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT scan
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Pidnarulex — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT scan

Study Details

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.

Key Dates

Start date
Oct 13, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (CX-5461)
    Patients receive CX-5461 IV over 60 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture with CSF collection on study and PET scan/CT scan, tumor biopsy, and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events (Phase 1) [ Time Frame: Up to 30 days after last dose of study treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Nicole Foley (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Nicole Foley (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Sami Ibrahimi (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Jing-Zhou Hou (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Oklahoma Health Sciences Center· Oklahoma City, OKUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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