Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
juin 2026
janvier 2030
01 novembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 04/11/2026 14:05:01 | Contacter | ||
Critères
Tous
- 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.
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.