Phase 2 Sonrotoclax, Zanubrutinib and Rituximab Trial for Follicular Lymphoma
ClinicalTrials.gov Studies
Summary
A Phase 2 clinical trial (NCT07550855) is evaluating a chemotherapy-free triplet regimen combining sonrotoclax, zanubrutinib, and rituximab in previously untreated patients with follicular lymphoma (FL). The trial targets two pathogenic mechanisms in FL: aberrant B-cell receptor signaling (via zanubrutinib, a next-generation BTK inhibitor) and impaired apoptosis driven by BCL2 overexpression (via sonrotoclax, a next-generation BCL2 inhibitor). Follicular lymphoma remains incurable for many patients despite high initial response rates to rituximab-based chemoimmunotherapy, with early progression including POD24 associated with poor long-term outcomes. The study is sponsored by BeiGene.
“In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.”
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What changed
A new Phase 2 clinical trial has been registered on ClinicalTrials.gov for a novel chemotherapy-free triplet regimen targeting previously untreated follicular lymphoma patients. The study combines sonrotoclax (a next-generation BCL2 inhibitor) with zanubrutinib (a next-generation BTK inhibitor) and rituximab. The trial addresses a medical need for more effective frontline treatment options, as current rituximab-based chemoimmunotherapy, while achieving high initial response rates, results in early progression for a substantial proportion of patients.
Healthcare providers and clinical investigators involved in follicular lymphoma treatment may encounter patients enrolled in this trial or similar studies. The trial's inclusion of BCL2 and BTK pathway targeting represents a shift toward chemotherapy-free approaches in B-cell lymphoma management. Pharmaceutical companies developing BTK or BCL2 inhibitors may find this trial relevant to competitive landscape and development strategy.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Sonrotoclax, Zanubrutinib and Rituximab in Previously Untreated Patients With Follicular Lymphoma
Phase 2 NCT07550855 Kind: PHASE2 Apr 24, 2026
Abstract
Follicular lymphoma (FL) remains an incurable indolent B-cell lymphoma for many patients, and although rituximab-based chemoimmunotherapy can achieve high initial response rates, a substantial proportion of patients experience early progression, including POD24, which is associated with poor long-term outcomes. This underscores the need for more effective and better-tolerated frontline treatment strategies, particularly chemotherapy-free approaches. The present study is based on a strong biologic rationale that simultaneously targets two key pathogenic mechanisms in FL: aberrant B-cell receptor signaling and impaired apoptosis driven by BCL2 overexpression. Zanubrutinib, a next-generation BTK inhibitor, has shown clinical activity with a favorable safety profile in FL, while sonrotoclax, a potent and highly selective next-generation BCL2 inhibitor, has demonstrated promising preclinical and early clinical activity. In combination with rituximab, this chemotherapy-free triplet regimen may produce deeper and more durable remissions while maintaining manageable toxicity, and therefore has the potential to expand frontline treatment options and improve outcomes for patients with previously untreated FL.
Conditions: Follicular Lymphoma (FL)
Interventions: Sotoclax in combination with zanubrutinib and rituximab regimen
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