RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Ryvu Therapeutics SA • ClinicalTrials.gov ID: NCT06534437

Registry updated: 2026-09-18

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Description

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.

Interventions

MEN1703 (Drug)
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 (Drug)
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.

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years old 2. Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma 3. Relapsed or refractory disease having received at least 2 prior lines of systemic treatment and, naïve to anti-CD3xCD20 bispecific antibody treatment (group 1) or exhausted all standard, available treatment options (group 2) 4. At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes. 5. Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only) 6. Life expectancy of ≥12 weeks. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 8. Adequate organ function at Screening 9. Adequate hematologic function Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening. 2. Received anti-cancer treatments, including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Prior treatment with CAR-T cell or an anti-CD3xCD20 bispecific antibody therapy (permitted for Group 2 only), requires a wash out period of ≥4 weeks. 3. Concurrent participation in another therapeutic clinical study. 4. Ongoing clinically significant toxicity (for example, alopecia is not clinically significant) from any prior anti-cancer therapy that has not resolved to Grade 1 or less prior to the first dose of study drug. 5. Prior treatment with a PIM inhibitor. 6. Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20. 7. Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients 8. Contraindication to all uric acid lowering agents. 9. Major surgery within 1 month prior to first dose of study drug. 10. Hematopoietic stem cell transplant within 4 months prior to first dose of study drug. 11. Requires systemic immune-modulating therapy (regardless of dose) or has confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression. 12. Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing the informed consent form (ICF). 13. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection, except for documented Grade Common Terminology Criteria for Adverse Events (CTCAE) ≤2 infections with evidence of improvement or without evidence of worsening infection. 14. Known human immunodeficiency virus (HIV) infection 15. Current active liver disease from any cause 16. Ongoing drug-induced pneumonitis. 17. Ongoing inflammatory bowel disease. 18. Active known second malignancy 19. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substrate with a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRP inhibitor within 14 days or 5 half-lives (whichever is shorter), prior to the first dose of study drug. 20. Cardiac dysfunction is defined as myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, or poorly controlled angina. 21. Receiving treatment for active, ongoing thromboembolic event. Note: Does not apply to prophylactic treatment to prevent or avoid reoccurrence of a prior resolved event. To review with Medical Monitor where further risk assessment is needed. 22. History of serious ventricular arrhythmia (e.g., VT or VF, ≥3 beats in a row), or QT interval corrected for heart rate (QTc) ≥480 ms. Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g., bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled. 23. Any disease, syndrome or condition which may significantly affect drug intake via oral route. 24. Planning to become pregnant or breastfeed during treatment and for 1 month after the last dose of study drug. 25. Any other prior or current medical condition, intercurrent illness, surgical history, physical or 12-lead electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.

Conditions

Non-Hodgkin Lymphoma, B-cell

Locations

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 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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