2025-524915-36-00RecruitingPhase 1/2
A study to evaluate safety and clinical activity of GSK5926371 in adult participants with relapsed or refractory B-NHL
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 22 Sept 2026
- Lead sponsor
- Glaxosmithkline Research & Development Limited
- Diseases
- Hodgkin lymphoma
- EU CT number
- 2025-524915-36-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- 16 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Not yet recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Not yet recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Not yet recruiting |
| Complejo Asistencial Universitario de Salamanca | Salamanca | Spain | Not yet recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Not yet recruiting |
| HUS-Yhtymae | Helsinki | Finland | Not yet recruiting |
| Tampere University Hospital | Tampere | Finland | Not yet recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Recruiting |
| Institut Gustave Roussy | Villejuif | France | Recruiting |
| Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria | Alexandria | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.