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MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
Sponsor: Ryvu Therapeutics SA
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
178
Start Date
2024-12-05
Completion Date
2026-12
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
MEN1703
MEN1703 (Dapolsertib hydrochloride) is a potent dual inhibitor of proviral integration site for Moloney murine leukemia virus (PIM) kinases and Fms-like tyrosine kinase 3 (FLT3).
Glofitamab
Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B-cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T-cells.
Locations (36)
Centre Hospitalier Le Mans
Le Mans, France
CHU de Lille - Hôpital Claude Huriez
Lille, France
CHU de Limoges - CHU Dupuytren
Limoges, France
Hospices Civils De Lyon - Hôpital Lyon Sud
Lyon, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France
APHP - Hôpital Pitié-Salpêtrière
Paris, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
Biała Podlaska, Poland
IN-VIVO Bydgoszcz Sp. z o.o.
Bydgoszcz, Poland
Klinika Hematologii I Transplantologii Uck
Gdansk, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy
Gliwice, Poland
Pratia Hematologia Sp. z o.o.
Katowice, Poland
Pratia MCM Kraków
Krakow, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Aidport Sp. z o.o.
Skórzewo, Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland
Lux Med Onkologia Sp. z o.o.
Warsaw, Poland
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland
Hospital Universitari Vall D Hebron
Barcelona, Spain
Clinica Universidad De Navarra
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Hospital Clínico Uni versitario Virgen de la Arrixaca
Murcia, Spain
Clinica Universidad De Navarra
Pamplona, Spain
Hospital Universitario De Navarra
Pamplona, Spain
Hospital Universitario De Salamanca
Salamanca, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Royal Marsden Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
The Royal Marsden Hospital
Sutton, United Kingdom
St George's Hospital
Tooting, United Kingdom