RecruitingPhase 2NCT06534437

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

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


Sponsor

Ryvu Therapeutics SA

Enrollment

178 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (JASPIS-01) tests MEN1703 (also called SEL24) — a dual PIM/FLT3 kinase inhibitor, a type of targeted therapy — in adults with aggressive B-cell non-Hodgkin lymphoma (including DLBCL and transformed indolent lymphomas) that has relapsed or not responded to multiple prior treatments. The drug targets proteins that help lymphoma cells survive. This study includes patients who haven't tried bispecific antibodies yet, and also patients who have exhausted all standard options. **You may be eligible if...** - You are 18 or older with confirmed aggressive B-cell non-Hodgkin lymphoma (such as DLBCL) - Your lymphoma has relapsed or not responded to at least 2 prior treatment lines (Group 1, bispecific-naive) OR you have exhausted all standard treatments (Group 2) - You have at least one measurable lymphoma lesion on a scan - You are in reasonably good health (ECOG 0-2) - Your organ function (liver, kidneys, heart) meets minimum thresholds - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your lymphoma involves the brain or spinal cord - You received another cancer treatment within 14 days (or 4 weeks for CAR-T/bispecific antibody) before starting - You have unresolved significant side effects from prior therapy - You have previously received a PIM inhibitor - You are in another concurrent clinical treatment trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMEN1703

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).

DRUGGlofitamab

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06534437


Related Trials