Clinical Trial

MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

Study acronym: JASPIS-01
Recruiting Phase 2
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Summary
The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time: * Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma * Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-07-30; most recent amendment 2025-09-23.
Status change: Not Yet Recruiting → Recruiting 2024-12-11
Trial Details
NCT Number NCT06534437
Lead Sponsor Ryvu Therapeutics SA
Collaborators: Menarini Group
Conditions Non-Hodgkin Lymphoma, B-cell
Enrollment 178 participants
Start Date 2024-12-05
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-29