Last updated: 05/19/2026 14:40:15

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

GSK study ID
300557
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of participants with dose limiting toxicities (DLTs)

Timeframe: Up to 28 days

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

Timeframe: Up to approximately 169 weeks

Secondary outcomes:

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

Timeframe: Up to approximately 169 weeks

Overall Response Rate (ORR)

Timeframe: Up to approximately 169 weeks

Maximum concentration (Cmax) of GSK5926371

Timeframe: Up to approximately 169 weeks

Time to Cmax (Tmax) of GSK5926371

Timeframe: Up to approximately 169 weeks

Area under the curve (AUC) of GSK5926371

Timeframe: Up to approximately 169 weeks

Interventions:
Drug: GSK5926371
Enrollment:
49
Observational study model:
Not applicable
Primary completion date:
2029-24-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Lymphoma, Non-Hodgkin
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2026 to September 2029
Type
Interventional
Phase
1/2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
  • a) Has measurable disease,
  • 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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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