A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL

NCT07607925 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 3005572025-524915-36
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities (DLTs)

  Up to 28 days

• Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity

  Up to approximately 169 weeks

Secondary Outcomes (5)

• Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)

  Up to approximately 169 weeks

• Overall Response Rate (ORR)

  Up to approximately 169 weeks

• Maximum concentration (Cmax) of GSK5926371

  Up to approximately 169 weeks

• Time to Cmax (Tmax) of GSK5926371

  Up to approximately 169 weeks

• Area under the curve (AUC) of GSK5926371

  Up to approximately 169 weeks

Study Arms (1)

GSK5926371

EXPERIMENTAL

Drug: GSK5926371

Interventions

GSK5926371 DRUG

GSK5926371 will be administered at different dose levels.

GSK5926371

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
• Has measurable disease,
• Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 27, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): September 24, 2029
• Study Completion (Estimated): September 24, 2029
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share