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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07607925




Registration number
Help: Registration number
NCT07607925
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
19/05/2026
Date registered
Help: Date registered
27/05/2026
Date last updated
Help: Date last updated
30/10/2026

Titles & IDs
Public title
A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL
Scientific title
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)
Additional trial identifiers [1] 0 0
2025-524915-36
Additional trial identifiers [2] 0 0
300557
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Lymphoma, Non-Hodgkin 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - GSK5926371

Experimental: GSK5926371 -


Treatment: Drugs: GSK5926371
GSK5926371 will be administered at different dose levels.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
Timepoint [2] 0 0
Up to approximately 169 weeks
Secondary outcome [1] 0 0
Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
Timepoint [1] 0 0
Up to approximately 169 weeks
Secondary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Up to approximately 169 weeks
Secondary outcome [3] 0 0
Maximum concentration (Cmax) of GSK5926371
Timepoint [3] 0 0
Up to approximately 169 weeks
Secondary outcome [4] 0 0
Time to Cmax (Tmax) of GSK5926371
Timepoint [4] 0 0
Up to approximately 169 weeks
Secondary outcome [5] 0 0
Area under the curve (AUC) of GSK5926371
Timepoint [5] 0 0
Up to approximately 169 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/01/2030
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Finland
State/province [5] 0 0
Helsinki
Country [6] 0 0
Finland
State/province [6] 0 0
Tampere
Country [7] 0 0
France
State/province [7] 0 0
Pierre-Bénite
Country [8] 0 0
France
State/province [8] 0 0
Rennes
Country [9] 0 0
France
State/province [9] 0 0
Villejuif
Country [10] 0 0
Italy
State/province [10] 0 0
MI
Country [11] 0 0
Italy
State/province [11] 0 0
Alessandria
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Japan
State/province [13] 0 0
Aichi
Country [14] 0 0
Japan
State/province [14] 0 0
Chiba
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Salamanca
Country [19] 0 0
Spain
State/province [19] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07607925