Study on the Safety and Effectiveness of GSK5926371 for Adults with Returning or Resistant B-Cell Blood Cancer
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT07607925
This clinical trial is testing a new drug, GSK5926371, to see if it can help treat a type of blood cancer called B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or hasn't responded to previous treatments. The study will focus on the safety and tolerability of the drug, as well as its effectiveness and how it behaves in the body.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the drug GSK5926371 can effectively treat adults with a type of blood cancer known as B-cell Non-Hodgkin Lymphoma (B-NHL) that has returned or not responded to previous treatments. The study will primarily look at how safe the drug is and how well patients can tolerate it. Additionally, researchers will assess how effective the drug is in treating the cancer and how it is processed in the body.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with B-cell Non-Hodgkin Lymphoma that has returned or not responded to treatment, and needs systemic treatment.
- Have measurable cancer that can be tracked.
- Have received at least two previous treatments, including one that targets CD20, which is appropriate for this type of cancer.
- The cancer must have returned, progressed, or not responded to the most recent treatment, according to specific medical criteria.
- Willing to use effective birth control if of childbearing potential.
- Able to provide informed consent to participate in the study.
- Have a performance status score between 0 and 2, indicating full activity or some restriction in strenuous activities.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have another type of cancer that has progressed or needed treatment in the past 24 months, except for certain skin cancers or in-situ cancers that have been removed.
- Have had major surgery within the past 4 weeks or have not fully recovered from surgery.
- Have a history of certain brain diseases or conditions, such as uncontrolled seizures or stroke.
- Have an active, uncontrolled infection.
- Have had an allogeneic stem cell transplant within the past 12 months or have active graft-versus-host disease.
- Have had an autologous stem cell transplant within the past 100 days.
- Have received CAR-T therapy within the past 12 weeks.
- Have received treatment with certain antibodies targeting CD19 or CD20 within the past 8 weeks.
- Have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
- Have significant heart disease, such as uncontrolled arrhythmias or recent heart attack.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| GSK Investigational Site | 52242 | Iowa City | Iowa |
| GSK Investigational Site | 10029 | New York | New York |
| GSK Investigational Site | 44718 | Canton | Ohio |
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