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New hope for Tough-to-Treat lymphoma: Two-Drug combo enters Mid-Stage trial

NCT ID NCT06534437

Disease control Sponsor: Ryvu Therapeutics SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This Phase 2 trial is testing a new drug called MEN1703, both alone and combined with another drug called glofitamab, in 178 adults with aggressive B-cell non-Hodgkin lymphoma that has come back or not responded to at least two prior treatments. The study aims to see if the drugs are safe and can shrink tumors. Participants are split into two groups: those who have not tried a certain type of immunotherapy, and those who have exhausted all standard options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MEN1703 (Dapolsertib hydrochloride) and Glofitamab
What this could lead to
If successful, this combination could offer a new treatment option for patients with aggressive B-cell lymphoma who have run out of standard therapies.
What could go wrong
This is an early Phase 2 trial with a small number of participants. The drugs may cause side effects, and it is not yet known if they will work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 178 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Aggression aggressive B-cell non-Hodgkin lymphoma B-cell non-Hodgkin lymphoma non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-Hodgkin lymphoma, B-cell

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP - Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, 75651, France

  • Aidport Sp. z o.o.

    RECRUITING

    Skórzewo, Poland

  • Beatson West of Scotland Cancer Centre

    RECRUITING

    Glasgow, United Kingdom

  • CHU Montpellier - Hôpital Saint Eloi

    RECRUITING

    Montpellier, 34490, France

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33600, France

  • CHU de Lille - Hôpital Claude Huriez

    RECRUITING

    Lille, France

  • CHU de Limoges - CHU Dupuytren

    RECRUITING

    Limoges, 87042, France

  • Centre Hospitalier Le Mans

    RECRUITING

    Le Mans, 72037, France

  • Clinica Universidad De Navarra

    RECRUITING

    Madrid, 28027, Spain

  • Clinica Universidad De Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospices Civils De Lyon - Hôpital Lyon Sud

    RECRUITING

    Lyon, 69310, France

  • Hospital Clínico Uni versitario Virgen de la Arrixaca

    NOT_YET_RECRUITING

    Murcia, 30120, Spain

  • Hospital Universitari Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario De Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Universitario De Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen De La Macarena

    RECRUITING

    Seville, 41009, Spain

  • IN-VIVO Bydgoszcz Sp. z o.o.

    RECRUITING

    Bydgoszcz, Poland

  • Klinika Hematologii I Transplantologii Uck

    NOT_YET_RECRUITING

    Gdansk, Poland

  • Lux Med Onkologia Sp. z o.o.

    TERMINATED

    Warsaw, Poland

  • MD Anderson Cancer Center

    RECRUITING

    Madrid, 28033, Spain

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy

    RECRUITING

    Gliwice, Poland

  • Plymouth Hospitals NHS Trust

    RECRUITING

    Plymouth, United Kingdom

  • Pratia Hematologia Sp. z o.o.

    TERMINATED

    Katowice, Poland

  • Pratia MCM Kraków

    RECRUITING

    Krakow, Poland

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    RECRUITING

    Krakow, Poland

  • St George's Hospital

    RECRUITING

    Tooting, United Kingdom

  • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

    RECRUITING

    Olsztyn, Poland

  • Szpitale Pomorskie Sp. z o.o.

    RECRUITING

    Gdynia, Poland

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, United Kingdom

  • The Royal Marsden Hospital

    RECRUITING

    Sutton, United Kingdom

  • Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

    TERMINATED

    Biała Podlaska, Poland

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

    RECRUITING

    Torun, Poland

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    TERMINATED

    Warsaw, Poland

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Other studies related to the condition(s) this trial covers.