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

Recruiting now · Phase 2

Conditions studied: Non-Hodgkin Lymphoma, B-cell

In brief

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.

Key facts

Study ID

NCT06534437

Run by

Ryvu Therapeutics SA

People needed

178

Starts

2024-12-05

Expected to finish

2026-12-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years old
• Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma
• 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)
• 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.
• Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)
• Life expectancy of ≥12 weeks.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
• Adequate organ function at Screening
• Adequate hematologic function

You may not qualify if…

• Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
• 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.
• Concurrent participation in another therapeutic clinical study.
• 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.
• Prior treatment with a PIM inhibitor.
• Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.
• Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients
• Contraindication to all uric acid lowering agents.
• Major surgery within 1 month prior to first dose of study drug.
• Hematopoietic stem cell transplant within 4 months prior to first dose of study drug.
• Requires systemic immune-modulating therapy (regardless of dose) or has confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression.
• Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing the informed consent form (ICF).
• 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.
• Known human immunodeficiency virus (HIV) infection
• Current active liver disease from any cause
• Ongoing drug-induced pneumonitis.
• Ongoing inflammatory bowel disease.
• Active known second malignancy
• 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.
• 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.
• 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.
• 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.
• Any disease, syndrome or condition which may significantly affect drug intake via oral route.
• Planning to become pregnant or breastfeed during treatment and for 1 month after the last dose of study drug.

Where it is running

• St George's Hospital — Tooting, United Kingdom (enrolling)
• CHU de Lille - Hôpital Claude Huriez — Lille, France (enrolling)
• CHU de Limoges - CHU Dupuytren — Limoges, France (enrolling)
• Hospices Civils De Lyon - Hôpital Lyon Sud — Lyon, France (enrolling)
• CHU Montpellier - Hôpital Saint Eloi — Montpellier, France (enrolling)
• APHP - Hôpital Pitié-Salpêtrière — Paris, France (enrolling)
• CHU de Bordeaux - Hôpital Haut-Lévêque — Pessac, France (enrolling)
• Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej — Biała Podlaska, Poland (enrolling)
• IN-VIVO Bydgoszcz Sp. z o.o. — Bydgoszcz, Poland (enrolling)
• Hospital Universitario De Navarra — Pamplona, Spain (enrolling)
• Hospital Universitario De Salamanca — Salamanca, Spain (enrolling)
• Hospital Universitario Virgen De La Macarena — Seville, Spain (enrolling)
• Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom (enrolling)
• The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
• Plymouth Hospitals NHS Trust — Plymouth, United Kingdom (enrolling)
• Centre Hospitalier Le Mans — Le Mans, France (enrolling)
• Szpitale Pomorskie Sp. z o.o. — Gdynia, Poland (enrolling)
• Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy — Gliwice, Poland (enrolling)
• Pratia Hematologia Sp. z o.o. — Katowice, Poland (enrolling)
• Pratia MCM Kraków — Krakow, Poland (enrolling)
• Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie — Olsztyn, Poland (enrolling)
• Aidport Sp. z o.o. — Skórzewo, Poland (enrolling)
• Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu — Torun, Poland (enrolling)
• Lux Med Onkologia Sp. z o.o. — Warsaw, Poland (enrolling)
• Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy — Warsaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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