A study to evaluate safety and clinical activity of GSK5926371 in adult participants with relapsed or refractory B-NHL
Trial overview
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
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
- 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.
- 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 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.:
- 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.
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.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
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.