A study to evaluate safety and clinical activity of GSK5926371 in adult participants with relapsed or refractory B-NHL

Trial details

Who runs it

Glaxosmithkline Research & Development Limited

Trial code

EU 2025-524915-36-00

Record updated

2026. szeptember 21.

Original description

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).Read full original descriptionShow less

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)

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).

Inclusion: 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.

Exclusion: 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.

EU CTIS 2025-524915-36-00