Lymphoma, Non-HodgkinPhase 1/2NCT07607925
A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL
A Phase 1/2 study testing GSK5926371 in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 22 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- GSK5926371
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 19 Jun 2026to 10 Jan 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 8 countries
Spain6 sites, 6 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08035
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Barcelona, 8036
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28040
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Madrid, 28041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Salamanca
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Valencia, 46010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
United States3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Canton, Ohio, 44718
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Iowa City, Iowa, 52242
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
New York, New York, 10029
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
France3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Pierre-Bénite, 69495
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rennes, 35033
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Villejuif, 94805
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Italy3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Alessandria, 15121
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Milan, 20133
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Rozzano, MI, 20089
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Japan3 sites, 3 recruiting
- Recruiting
GSK Investigational Site
Aichi, 460-0001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Chiba, 277-8577
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Finland2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Helsinki, 00290
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tampere, 33520
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Heidelberg, Victoria, 3084
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Toronto, Ontario, M5G 1X6
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official 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)
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
- Being tested
- GSK5926371
- Keywords
- Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL), GSK5926371
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK5926371Drug
GSK5926371 will be administered at different dose levels.
| Study group | Role | What they receive |
|---|---|---|
| GSK5926371 | Experimental | Not described Receives: Drug: GSK5926371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
Measured: Up to 28 days
Number of participants with adverse events (AEs) or Serious adverse events (SAEs) by severity
Measured: Up to approximately 169 weeks
Secondary outcomes (5)
Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
Measured: Up to approximately 169 weeks
Overall Response Rate (ORR)
ORR is defined as the percentage of participants in the ORR evaluable set with the best overall response of confirmed partial response (PR) or better per Lugano guidelines as assessed by investigator.
Measured: Up to approximately 169 weeks
Maximum concentration (Cmax) of GSK5926371
Measured: Up to approximately 169 weeks
Time to Cmax (Tmax) of GSK5926371
Measured: Up to approximately 169 weeks
Area under the curve (AUC) of GSK5926371
Measured: Up to approximately 169 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start19 Jun 2026
- Primary completion10 Jan 2030 (estimated)
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607925
- Sponsor's protocol ID
- 300557
- Other IDs
- 2025-524915-36, 2025-524915-36, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07607925
- Acronym / sponsor ID
- 300557
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL), GSK5926371
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 10 Jan 2030 (estimated)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK5926371 | Experimental | Drug: GSK5926371 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK5926371GSK5926371 will be administered at different dose levels. | Drug | GSK5926371 |
Primary outcome
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
5 secondary outcomes
Number of participants with clinically meaningful changes in laboratory parameters, vital signs, and electrocardiogram (ECG)
Time frame: Up to approximately 169 weeks
Overall Response Rate (ORR)
Time frame: Up to approximately 169 weeks
Maximum concentration (Cmax) of GSK5926371
Time frame: Up to approximately 169 weeks
Time to Cmax (Tmax) of GSK5926371
Time frame: Up to approximately 169 weeks
Area under the curve (AUC) of GSK5926371
Time frame: Up to approximately 169 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GSK5926371 in people with Lymphoma, Non-Hodgkin, run by GlaxoSmithKline at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain, United States, France, Italy, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.