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Taking peoplePhase 1/2

Testing the experimental drug GSK5926371 in adults with relapsed or hard-to-treat B-cell lymphoma

Tests GSK5926371 in adults whose B-cell non-Hodgkin lymphoma returned or resisted treatment.

Key facts

Who runs it
Glaxosmithkline Research & Development Limited
Where
Freiburg im Breisgau and Mainz, GermanySee the 2 sitesAlso in 4 other countries, 14 sites
Registry title
A study to evaluate safety and clinical activity of GSK5926371 in adult participants with relapsed or refractory B-NHL
Status
Recruiting
Phase
Phase 1/2
People taking part
30 people, planned
Started
22 Sept 2026
Expected to end
24 Sept 2029
Type of study
Interventional
Record updated
21 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose B-cell non-Hodgkin lymphoma came back or did not respond to treatment, after at least 2 earlier lines of treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Histologically confirmed B-cell non-Hodgkin lymphoma that came back or did not respond to the latest treatment, with measurable disease, needing systemic treatment. ECOG performance status of 0 to 2.
Earlier treatment
At least 2 prior lines of systemic anti-cancer treatment, including an anti-CD20 combination. If CD19-directed CAR-T therapy is approved for the lymphoma type, it must have been given, unless the person cannot have it, cannot get it or declined it.

Main reasons for not taking part

  • Another cancer that progressed or needed treatment in the past 24 months (some skin and in-situ cancers excepted)
  • Serious heart disease, such as uncontrolled arrhythmias or a heart attack within 6 months
  • Lymphoma in the central nervous system, or a history of PML or serious brain or nerve disease
  • Infection needing antibiotic, antifungal or antiviral treatment within 14 days before the first dose
  • Recent stem cell transplant, CAR-T therapy or CD19/CD20 bispecific antibody treatment within the time limits in the record

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Is at least 18 years of age at the time of signing the ICF
  • Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated, a) Has measurable disease, b) Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication. For indications for which CD19-directed CAR-T therapy is approved, the participant must have received such prior CAR-T therapy unless deemed ineligible, does not have access to it or has declined this treatment; c) Has documented disease relapse, progression or disease refractory to the most recent line of therapy, per Lugano criteria
  • Willing to use adequate contraception (Participant of childbearing potential [POCBP] only)
  • Is capable of giving signed informed consent
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Has adequate organ function

Who cannot take part

  • Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications
  • Has an active or chronic infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug
  • Has received a prior Allogeneic stem cell transplant (allo-SCT) within 12 months prior to the first dose of GSK5926371 or has active graft-versus-host disease requiring systemic immunosuppressive therapy
  • Has received a prior autologous stem cell transplant within 100 days prior to the first dose of GSK5926371
  • Has received prior treatment with Chimeric antigen receptor Tcell (CAR-T) therapy within 12 weeks of first GSK5926371 administration
  • Has received prior treatment with CD19- or CD20-targeting Bispecific antibody (BsAbs) within 8 weeks of the first dose of study intervention
  • Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease
  • Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions
  • Has significant cardiovascular disease such as uncontrolled arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction  45% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment
  • Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block

Where in Germany

Also in 4 other countries, 14 sites

  • Medical Center- University of FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyNot yet recruiting

About the trial

What the trial wants to find out

To evaluate the safety and tolerability of GSK5926371 in participants with relapsed or refractory B-NHL to establish the Recommended dose for expansion (RDE) and/or Recommended Phase 2 dose(s) (RP2D).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)
Plain-language title
Testing the experimental drug GSK5926371 in adults with relapsed or hard-to-treat B-cell lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
21 September 2026