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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 Lymphoma (B NHL)

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

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Pending

June. 12, 2026

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

single assignment

treatment purpose

- Participants >18 years of age
- 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;
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.

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.

Both

B-cell Non-Hodgkin Lymphoma

GSK5926371 will be administered at different dose levels.

Incidence of DLTs per dose level in the DLT observation period.
Incidence and severity of AEs/SAEs.

Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
Overall Response Rate (ORR)
Maximum concentration (Cmax) of GSK5926371
Time to Cmax (Tmax) of GSK5926371
Area under the curve (AUC) of GSK5926371

+81-3-3520-0111

May. 13, 2026

Yes

[Plan Description] IPD for this study will be made available via the Clinical Study Data Request site. [URL] http://clinicalstudydatarequest.com

USA/Canada/Australia/France/Germany/Italy/Spain/Finland