Clinical Trial: NCT06534437
MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
Status:
RECRUITINGPhase:
Phase 2| Lead Sponsor: | Ryvu Therapeutics SA |
| Information Provided By: | Ryvu Therapeutics SA |
| Last Update Posted: | 2026-09-18 |
Study Overview
Brief 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.
Official Title
An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Conditions
Non-Hodgkin Lymphoma, B-cell
Intervention / Treatment
- Drug: MEN1703
- Drug: Glofitamab
Other Study ID Numbers
- JASPIS-01
Start Date (Actual)
2024-12-05
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2026-12
Enrollment (Estimated)
178
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Ryvu Therapeutics SA |
| Information Provided By: | Ryvu Therapeutics SA |
| Last Update Posted: | 2026-09-18 |
Study Overview
Brief 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.
Official Title
An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
Conditions
Non-Hodgkin Lymphoma, B-cell
Intervention / Treatment
- Drug: MEN1703
- Drug: Glofitamab
Other Study ID Numbers
- JASPIS-01
Start Date (Actual)
2024-12-05
Primary Completion Date (Estimated)
2026-12
Study Completion Date (Estimated)
2026-12
Enrollment (Estimated)
178
Study Type
Interventional
Phase
Phase 2