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Phase 1/2 Study Evaluating Safety and Activity of GSK5926371 in Adults with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have a type of blood cancer called B-cell Non-Hodgkin Lymphoma that has come back after treatment or does not respond to standard therapy. The investigational medicine being tested is a laboratory‑made protein given as a subcutaneous injection, identified by the code name GSK5926371. This medication is designed to target the cancer cells directly.

The purpose of the trial is to evaluate the safety and clinical activity of the drug and to determine the appropriate dose for later studies. Participants will receive a series of injections over several weeks while doctors monitor them closely for any signs of dose limiting toxicities, adverse events or serious adverse events. Routine visits will include blood work, checks of vital signs such as blood pressure and heart rate, and an electrocardiogram (ECG) to record the heart’s electrical activity.

Additional evaluations will look at how well the cancer responds, measured by the Overall Response Rate (ORR), and will also assess how the drug behaves in the body, including its Maximum concentration (Cmax), the time it takes to reach that level (Time to Cmax (Tmax)), and the total exposure over time (Area under the curve (AUC)). These assessments help researchers understand both the effectiveness and the safety profile of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After you join the study, you will undergo baseline assessments that include a review of your medical history, blood tests, vital sign measurements, and an electrocardiogram (ecg) to record the electrical activity of your heart.

    These assessments help the study team understand your current health status before receiving any study medication.

  2. Step 2

    First dose administration

    On the first day of treatment you will receive an injection of gsk5926371 under the skin (subcutaneous use). the medication is provided as a solution for injection.

    The exact amount of medication and how often it will be given are determined by the study protocol and will be explained to you by the study staff.

  3. Step 3

    Regular treatment cycles

    You will continue to receive subcutaneous injections of gsk5926371 according to the schedule set by the study protocol.

    Each time you receive the medication, you will be monitored for safety with repeat blood tests, vital sign checks, and ecg recordings.

  4. Step 4

    Safety monitoring

    Throughout the study you will be evaluated for dose limiting toxicities, which are side effects that may require a change in dosage or stopping the medication.

    Any adverse events or serious adverse events, meaning any new or worsening health problems, will be recorded and assessed for severity.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period you will undergo a final set of assessments, including blood tests, vital sign measurements, and ecg, to evaluate the overall response to the medication.

    The results will be used to help determine the recommended dose for future studies.

Who can join the trial?

10 criteria

  • You must be at least 18 years old when you sign the study’s written permission form (called an informed consent form).
  • You need a diagnosis that a doctor has confirmed by looking at tissue under a microscope (histologically confirmed) of relapsed or refractory B‑cell non‑Hodgkin lymphoma (B‑NHL). This means the cancer has come back or did not respond to earlier treatments.
  • Your disease must be measurable, meaning doctors can see and track it with scans or tests.
  • You must have had at least two previous rounds of systemic anti‑cancer therapy (treatments that affect the whole body), and one of those treatments must have included a medicine that targets the protein called CD20.
  • If a treatment called CD19‑directed CAR‑T therapy is approved for your type of lymphoma, you must have already received it unless you were not eligible, could not get it, or chose not to have it.
  • You must have documented evidence that your disease has relapsed, progressed, or is refractory after the most recent treatment, according to the Lugano criteria (a set of rules doctors use to define cancer status).
  • If you could become pregnant, you must agree to use reliable birth control methods (contraception) during the study.
  • You must be able to understand the study and sign the informed consent form (informed consent).
  • You need an ECOG performance status of 0, 1, or 2, which means you are fully active (0) or able to carry out most daily activities (1‑2) without being bedridden.
  • You must have adequate organ function, meaning your heart, liver, kidneys, and other major organs are working well enough for the study.

Who cannot join the trial?

10 criteria

  • Having another cancer (besides the lymphoma being studied) that has gotten worse or needed treatment in the past 24 months, except for certain skin cancers called basal cell carcinoma or squamous cell carcinoma, or early‑stage cancers of the breast, cervix, or bladder that have been removed and have not spread (no metastatic disease).
  • Having serious heart problems such as uncontrolled irregular heartbeat (arrhythmias), severe heart failure (Class 3 or 4 on the New York Heart Association scale), a heart‑pumping ability (ejection fraction) of 45 % or lower, or recent unstable chest pain or heart attack (unstable angina or myocardial infarction) within the last 6 months.
  • Having had a major operation within 4 weeks before the first dose of the study drug, or not fully recovered from a recent surgery or its complications.
  • Having a history of Progressive multifocal leukoencephalopathy (PML), current involvement of the brain or spinal cord (central nervous system, CNS) by lymphoma, or a history of serious brain conditions such as uncontrolled seizures, stroke, epilepsy, inflammation of brain blood vessels (vasculitis), or progressive brain diseases (neurodegenerative conditions).
  • Having an active or ongoing infection that requires antibiotics, antifungal, or antiviral medicines (systemic antibacterial/antifungal/antiviral therapy) within 14 days before the first dose.
  • Having received a donor (allogeneic) stem cell transplant within the past 12 months, or having ongoing graft‑versus‑host disease that needs medicines to suppress the immune system (immunosuppressive therapy).
  • Having received your own (autologous) stem cell transplant within 100 days before the first dose.
  • Having had CAR‑T cell therapy (a special immune‑based treatment) within 12 weeks before the first dose.
  • Having had a CD19‑ or CD20‑targeting bispecific antibody (a type of engineered drug) within 8 weeks before the first dose.
  • Having a prolonged heart electrical interval (QTc) longer than 450 milliseconds, or longer than 480 milliseconds if you have a bundle branch block (a type of heart conduction problem).
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Investigated drugs

GSK5926371 is an experimental medicine being studied in adults whose B‑cell non‑Hodgkin lymphoma has come back or did not respond to previous treatments. It is given as a liquid that is injected just under the skin. In this trial the drug is being evaluated to see if it is safe, how well patients can tolerate it, and whether it shows any activity against the cancer. The information gathered will help researchers decide the appropriate dose for later studies.

What is already known about the treatment

GSK5926371 - It is given as a solution for injection under the skin (subcutaneous use). The drug is still investigational and is being studied in early‑phase clinical trials, so it has not received any regulatory approval yet. It is being tested for the treatment of relapsed or refractory B‑cell non‑Hodgkin lymphoma. GSK5926371 works by blocking a specific protein that helps the cancer cells grow, classifying it as an experimental targeted small‑molecule therapy.

Investigated diseases

non-Hodgkin lymphoma (NHL) - non-Hodgkin lymphoma is a group of cancers that start in the lymphatic system, usually from B‑cell lymphocytes. It often begins with swollen lymph nodes and can spread to the spleen, bone marrow, or other organs. The disease may stay localized for a time or become more widespread, leading to involvement of multiple body sites. Over time, some forms can change from slow‑growing to faster‑growing behavior.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524915-36-00Protocol code300557Estimated enrolment49 patientsSponsorGlaxosmithkline Research & Development Limited

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