Pidnarulex for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CX-5461 (Pidnarulex) for individuals with certain aggressive B-cell non-Hodgkin lymphoma types. The goal is to determine if this treatment can safely halt cancer cell growth by blocking essential enzymes and to identify the most effective dose. Suitable participants have specific lymphoma subtypes, such as double-expressor lymphoma, have previously tried other treatments, and have no other effective options available. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking strong CYP3A4 inhibitors or inducers, as they may interact with the trial drug. If you're unsure about your medications, it's best to discuss with the trial's medical team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that CX-5461, also known as Pidnarulex, might be safe and manageable for people with B-cell non-Hodgkin lymphoma. In earlier studies, patients used CX-5461 to test its effectiveness against cancer cells. These studies suggested that the drug can be safely administered, although, like many cancer treatments, it can have side effects.
CX-5461 has been tested in people before, including those with other types of cancer, which provides some confidence in its safety for ongoing trials. However, as with any treatment, side effects may occur, and patients should discuss these risks with their doctors.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy and immunotherapy treatments for lymphoma, Pidnarulex (CX-5461) offers a unique approach by targeting a specific enzyme crucial for cancer cell survival. This drug inhibits RNA polymerase I, which is responsible for ribosomal RNA synthesis—a process essential for the rapid growth of cancer cells. Researchers are excited because this mechanism is not only novel but also offers the potential to overcome resistance seen with traditional therapies, possibly leading to more effective and durable responses in patients.
What evidence suggests that CX-5461 might be an effective treatment for B-cell non-Hodgkin lymphoma?
Research has shown that CX-5461, also known as Pidnarulex, may help treat B-cell non-Hodgkin lymphoma. Early studies demonstrated strong effects against cancer both alone and in combination with other treatments. In this trial, participants will receive CX-5461 as the investigational treatment. Some patients with B-cell lymphoma responded well to CX-5461, particularly those with tumors driven by the MYC gene. For instance, one patient experienced a partial response, with their cancer shrinking temporarily. This drug works by blocking certain enzymes that cancer cells need to grow, potentially stopping or slowing the cancer's progress.16789
Who Is on the Research Team?
Sami Ibrahimi
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
Adults with certain aggressive B-cell non-Hodgkin lymphomas who've tried at least one treatment without success can join. They need a decent level of health, enough platelets and white blood cells, normal liver function, good kidney performance, and controlled HIV or hepatitis B if present.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive CX-5461 IV over 60 minutes on days 1 and 8 of each 21-day cycle. Lumbar puncture, PET/CT scans, tumor biopsy, and blood sample collection are conducted throughout the study.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days post-treatment, every 3-4 months for the first 2 years, and every 6 months for years 3-5.
What Are the Treatments Tested in This Trial?
Interventions
- CX-5461 (Pidnarulex)
Trial Overview
The trial is testing CX-5461 (Pidnarulex), which might block enzymes that cancer cells need to grow. It's for patients with specific genetic changes in their lymphoma. The study includes finding the safest dose and will use tests like lumbar puncture and CT scans to see how well it works.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
The G-quadruplex ligand CX-5461: an innovative candidate ...
Subsequently, in a range of preclinical cancer models, CX-5461 exhibited excellent anti-cancer effects both as a monotherapy and combination ...
Senhwa Biosciences CX-5461 Secures NCI Support to ...
... CX-5461 delivered promising results in patients with B-cell lymphoma. ... CX-5461 has demonstrated potential efficacy in MYC gene-driven tumors.
3.
dfhcc.harvard.edu
dfhcc.harvard.edu/fileadmin/media/ETCTN/02_Developing_an_ETCTN_Study/PTMA_Requests/Pidnarulex_NSC_845292_PTMA.pdfFOR CONDUCTING CLINICAL TRIALS USING ...
One patient with anaplastic large cell lymphoma experienced a prolonged partial response (PR) and five patients with myeloma and diffuse large B ...
Testing the Safety of Anti-Cancer Drug, CX-5461 ...
Giving CX-5461 may be safe, tolerable and/or effective in treating patients with B-cell non-Hodgkin lymphoma. Eligibility Criteria. Inclusion Criteria.
CX-5461 activates the DNA damage response and ...
Taken together, our data suggest CX-5461 may provide therapeutic benefit in the high-MYCN HGSOC subtype classified with elevated functional MYC ...
Study Details | NCT07137416 | Testing the Safety of the ...
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor ...
Senhwa Biosciences Clinical Data Abstract
Senhwa Biosciences' new drug Pidnarulex (CX-5461) has demonstrated efficacy in treating various solid tumors with BRCA2 or PALB2 gene defects.
Reply to: The chemotherapeutic drug CX-5461 is a potent ...
Samples from 4 patients were obtained from patients enrolled in the first-in-human Phase I study of CX-5461 (ACTRN12613001061729), which ...
9.
prnewswire.com
prnewswire.com/news-releases/senhwa-biosciences-presents-clinical-data-abstract-on-pidnarulex-at-2024-esmo-congress-302241441.htmlSenhwa Biosciences Presents Clinical Data Abstract on ...
The study involved end-stage oncology patients with no other suitable treatment options. In this Phase Ib study, Pidnarulex (CX-5461) ...
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