MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Part 1: Incidence and severity of adverse events (AE) — 12 months
Assessed as the number and grade of adverse events assessed by CTCAE v5.0 - Part 2 and Part 3: Complete response (CR) (group 1) — 12 months
Assessed per Lugano Response Criteria for Malignant Lymphoma - Part 2 and Part 3: Overall response rate (group 2) — 12 months
Assessed as the number of patients who achieve a complete response (CR) or partial response (PR), per Lugano Response Criteria, divided by the total number of evaluable patients
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Hospitalier Le Mans | Le Mans | France | Recruiting |
| CHU de Lille - Hôpital Claude Huriez | Lille | France | Recruiting |
| CHU de Limoges - CHU Dupuytren | Limoges | France | Recruiting |
| Hospices Civils De Lyon - Hôpital Lyon Sud | Lyon | France | Recruiting |
| CHU Montpellier - Hôpital Saint Eloi | Montpellier | France | Recruiting |
| APHP - Hôpital Pitié-Salpêtrière | Paris | France | Recruiting |
| CHU de Bordeaux - Hôpital Haut-Lévêque | Pessac | France | Recruiting |
| Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej | Biała Podlaska | Poland | Terminated |
| IN-VIVO Bydgoszcz Sp. z o.o. | Bydgoszcz | Poland | Recruiting |
| Klinika Hematologii I Transplantologii Uck | Gdansk | Poland | Not Yet Recruiting |
| Szpitale Pomorskie Sp. z o.o. | Gdynia | Poland | Recruiting |
| Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy | Gliwice | Poland | Recruiting |
| Pratia Hematologia Sp. z o.o. | Katowice | Poland | Terminated |
| Pratia MCM Kraków | Krakow | Poland | Recruiting |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | Poland | Recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | Poland | Recruiting |
| Aidport Sp. z o.o. | Skórzewo | Poland | Recruiting |
| Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun | Poland | Recruiting |
| Lux Med Onkologia Sp. z o.o. | Warsaw | Poland | Terminated |
| Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy | Warsaw | Poland | Terminated |
| Hospital Universitari Vall D Hebron | Barcelona | Spain | Recruiting |
| Clinica Universidad De Navarra | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro Majadahonda | Madrid | Spain | Recruiting |
| Hospital Clínico Uni versitario Virgen de la Arrixaca | Murcia | Spain | Not Yet Recruiting |
| Clinica Universidad De Navarra | Pamplona | Spain | Recruiting |
| Hospital Universitario De Navarra | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca | Salamanca | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena | Seville | Spain | Recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Recruiting |
| Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
| Plymouth Hospitals NHS Trust | Plymouth | United Kingdom | Recruiting |
| The Royal Marsden Hospital | Sutton | United Kingdom | Recruiting |
| St George's Hospital | Tooting | United Kingdom | Recruiting |
More Ryvu Therapeutics SA trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06534437 on ClinicalTrials.gov ↗ ← All trials in Spain