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Non-Hodgkin Lymphoma, B-cellPhase 2JASPIS-01NCT06534437

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

A Phase 2 study testing MEN1703 and Glofitamab in people with Non-Hodgkin Lymphoma, B-cell, run by Ryvu Therapeutics SA at 35 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma, B-cell
What is being tested?
MEN1703 and Glofitamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
35 sitesin 4 countries
Study dates
5 Dec 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
  • Adequate organ function at Screening
  • Adequate hematologic function

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.
  • 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.

Trial locations and contacts

35 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Head of Clinical Operations contact

+48 123140200

clinicaltrials@ryvu.com

35 sites in 4 countries

Poland13 sites, 9 recruiting

  • Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

    Biała Podlaska

    Terminated

  • IN-VIVO Bydgoszcz Sp. z o.o.

    Bydgoszcz

    Jarosław Czyż, Prof.

    Recruiting

  • Klinika Hematologii I Transplantologii Uck

    Gdansk

    Jan Zaucha, Prof.

    Not yet recruiting

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia

    Adam Witkowski, MD PhD

    Recruiting

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

    Gliwice

    Małgorzata Krawczyk-Kuliś, Prof.

    Małgorzata Krawczyk-Kuliś, Prof.

    Recruiting

  • Pratia Hematologia Sp. z o.o.

    Katowice

    Terminated

  • Pratia MCM Kraków

    Krakow

    Wojciech Jurczak, Prof.

    Wojciech Jurczak, Prof.

    Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow

    Agnieszka Giza, MD PhD

    Recruiting

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

    Olsztyn

    Janusz Hałka, MD PhD

    Janusz Hałka, MD PhD

    Recruiting

  • Aidport Sp. z o.o.

    Skórzewo

    Michał Kwiatek, Dr

    Recruiting

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Torun

    Dominik Chraniuk, MD

    Dominik Chraniuk, MD

    Recruiting

  • Lux Med Onkologia Sp. z o.o.

    Warsaw

    Terminated

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw

    Terminated

Other trials in Poland

Spain10 sites, 10 recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

    Crisitna Garcia Herce, MD PhD

    Recruiting

  • Clinica Universidad De Navarra

    Madrid, 28027

    Miguel Angel Canales Albendea, MD PhD

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Adolfo De La Fuente Burguera, MD PhD

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid

    Mariano Provencio Pulla, MD PhD

    Recruiting

  • Hospital Clínico Uni versitario Virgen de la Arrixaca

    Murcia, 30120

    Ignacio Espanol Morales, Dr

    Not yet recruiting

  • Clinica Universidad De Navarra

    Pamplona, 31008

    Miguel Angel Canales Albendea, MD PhD

    Recruiting

  • Hospital Universitario De Navarra

    Pamplona, 31008

    Jose Maria Arguinano Perez, MD PhD

    Recruiting

  • Hospital Universitario De Salamanca

    Salamanca, 37007

    Norma Carmen Gutierrez, Prof.

    Recruiting

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009

    Natalia Palazon, MD PhD

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza

    Araceli Rubio Martinez, MD PhD

    Recruiting

Other trials in Spain

France7 sites, 7 recruiting

  • Centre Hospitalier Le Mans

    Le Mans, 72037

    Kamel Laribi, MD PhD

    Recruiting

  • CHU de Lille - Hôpital Claude Huriez

    Lille

    Franck Morschhauser, Prof.

    Recruiting

  • CHU de Limoges - CHU Dupuytren

    Limoges, 87042

    Julie Abraham, MD PhD

    Recruiting

  • Hospices Civils De Lyon - Hôpital Lyon Sud

    Lyon, 69310

    Herve Ghesquieres, Prof.

    Recruiting

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34490

    Guillaume Cartron, MD PhD

    Recruiting

  • APHP - Hôpital Pitié-Salpêtrière

    Paris, 75651

    Sylvain Choquet, MD PhD

    Recruiting

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33600

    Francois Xavier Gros, MD PhD

    Recruiting

Other trials in France

United Kingdom5 sites, 5 recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow

    Mark Rafferty, Dr

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Kim Linton, Dr

    Recruiting

  • Plymouth Hospitals NHS Trust

    Plymouth

    David Burns, Dr

    Recruiting

  • The Royal Marsden Hospital

    Sutton

    David Cunningham, Dr

    Recruiting

  • St George's Hospital

    Tooting

    Ruth Pettengell, Dr

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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

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.
Read the detailed description

The study consists of 3 parts, to investigate MEN1703 (Dapolsertib hydrochloride) in combination with glofitamab in patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) or MEN1703 alone in patients who have exhausted all standard treatment options (group 2).

Part 1 (safety run-in) and Part 2 (enrichment): patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will receive either 150 mg or 125 mg of MEN1703 along with glofitamab. Patients who have exhausted all standard treatment options (group 2) will receive 125 mg of MEN1703 as a single-agent.

Part 3 (optional randomized comparison): Patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody therapy will be randomized to receive either MEN1703 (Dapolsertib hydrochloride) at a dose selected from part 2 in combination with glofitamab or glofitamab alone.

Being tested
MEN1703, Glofitamab
Keywords
Relapsed, Refractory, Aggressive
Medical subject headings
Lymphoma, Non-Hodgkin, Recurrence, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEN1703Drug

    Also called SEL24, Dapolsertib hydrochloride

    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).

  • GlofitamabDrug

    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 groups in NCT06534437
Study groupRoleWhat they receive
MEN1703 + glofitamabExperimental• Participants who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will be given MEN1703 orally at a dose of 150 mg daily for 7 days or 125 mg daily for 14 days, in 21-day cycles for a maximum of 12 cycles, in combination with glofitamab administered as an IV infusion in a step-up dosing schedule starting with 2.5 mg on day 8 of cycle 1, and10 mg on day 15 of cycle 1, and 30 mg on day 1 from cycle 2 onward until disease progression or withdrawal, for a maximum of 12 cycles (parts 1, 2, 3)). All participants will be administered 1,000 mg of obinutuzumab as an IV infusion on cycle 1 day 1. • Participants who have exhausted all standard treatment options (group 2) will receive MEN1703 as a single-agent, at a dose of 125 mg orally every-day for 14 consecutive days in consecutive 21-day treatment cycles, until progressive disease (parts 1 and 2).
Receives: Drug: MEN1703; Drug: Glofitamab
GofitamabActive comparatorParticipants who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will receive glofitamab as a single-agent administered as an IV infusion in a step-up dosing schedule starting with 2.5 mg on day 8 of cycle 1, and10 mg on day 15 of cycle 1, and 30 mg on day 1 from cycle 2 onward until disease progression or withdrawal, for a maximum of 12 cycles (part 3).
Receives: Drug: Glofitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence and severity of adverse events (AE)

    Assessed as the number and grade of adverse events assessed by CTCAE v5.0

    Measured: 12 months

  2. Part 2 and Part 3: Complete response (CR) (group 1)

    Assessed per Lugano Response Criteria for Malignant Lymphoma

    Measured: 12 months

  3. Part 2 and Part 3: Overall response rate (group 2)

    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

    Measured: 12 months

Secondary outcomes (12)

  1. Part 2 and Part 3, Incidence and severity of AE

    Assessed as the number and grade of adverse events assessed by CTCAE v5.0

    Measured: 12 months

  2. Maximum Plasma Concentration (Cmax)

    Assessment of the peak plasma concentration (Cmax)

    Measured: 12 months

  3. Maximum Plasma Concentration (Tmax)

    Assessment of the time to peak plasma concentration (Tmax)

    Measured: 12 months

  4. Area Under the Concentration Time-Curve (AUC)

    Assessed of the area under the plasma concentration versus time curve (AUC)

    Measured: 12 months

  5. Impact of treatment on patient reported outcomes (PRO)

    Assessed as changes in lymphoma symptoms, well-being, and general health status measured according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) consisting of 30 questions that assess five domains of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status/quality of life (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All are scored from 0 to 100, with higher scores on the five domains and GHS/QoL being reflective of better health related (HR) QoL, and higher scores on the symptom scales and single items reflective of poor HRQoL.

    Measured: 12 months

  6. Impact of treatment on quality of life (QOL)

    Assessed as changes in lymphoma symptoms and health related quality of life (HRQoL) as measured using the 15-item Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) including physical, social/family, emotional, and functional well-being and includes a lymphoma-specific subscale. The scale range is 0 to 60, with a higher score reflecting a better HRQoL.

    Measured: 12 months

  7. Overall survival (OS)

    Assessed as the time from first treatment to death.

    Measured: 12 months

  8. Progression-free survival (PFS)

    Assessed as time from the time from first treatment to the first occurrence of disease progression or death.

    Measured: 12 months

  9. Duration of Response (DoR)

    Assessed as the time from first response (CR or PR) to the first occurrence of disease progression or death.

    Measured: 12 months

  10. Duration of Complete Response (DoCR)

    Assessed as the time from first complete response (CR) to the first occurrence of disease progression or death.

    Measured: 12 months

  11. Time to response

    Assessed as the time from the first treatment to the time of first response (CR or PR).

    Measured: 12 months

  12. Time to next treatment

    Assessed as the time from the first treatment to the start date of the first therapy received after the participant has ended study treatment and received subsequent anti-lymphoma therapy.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start5 Dec 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534437
Sponsor's protocol ID
JASPIS-01
Acronym
JASPIS-01
Status last verified
Sep 2026
First submitted
30 Jul 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEN1703 and Glofitamab in people with Non-Hodgkin Lymphoma, B-cell, run by Ryvu Therapeutics SA at 35 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Poland, Spain, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head of Clinical Operations (+48 123140200, clinicaltrials@ryvu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence and severity of adverse events (AE) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06534437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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