Recruiting
Phase 1
Phase 2

GSK5926371

Sponsor:

GlaxoSmithKline

Code:

NCT07607925

Conditions

Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GSK5926371

Study Details

Brief summary:

The goal of this clinical trial is to learn if drug GSK5926371 works to treat a form of B-cell cancer (a type of blood cancer) that has returned or failed to respond to prior therapies in adults. The study will primarily assess the drugs safety and tolerability in participants. Additionally, it seeks to determine the clinical efficacy and pharmacokinetic (PK) properties of GSK5926371.

Conditions

Lymphoma, Non-Hodgkin

Study ID

NCT07607925

Start date

Jun 19, 2026

Status verified date

Oct, 2026

Completion date

Jan 10, 2030

Anticipated

Primary completion date

Jan 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,

1. Has measurable disease,
2. Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;
3. 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 Criteria:

  • 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 had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.
  • 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 an active uncontrolled infection.
  • 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 T-cell (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 QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.
  • 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.

Study Design

Enrollment

49 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GSK5926371

Interventions

GSK5926371

GSK5926371 will be administered at different dose levels.

Primary outcome measure

  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity [ Time Frame: Up to approximately 169 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nanmeng Yu

GSK Investigational Site

Recruiting

New York, New York, United States, 10029

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

roshan asrani

GSK Investigational Site

Recruiting

Canton, Ohio, United States, 44718

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nashat Gabrail

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Kuruvilla

More Information

Sponsor

GlaxoSmithKline

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)
  • GSK5926371

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.