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Looking for participantsPhase2

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

Sponsor: Ryvu Therapeutics SA

NCT ID: NCT06534437

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MEN1703 (drug), Glofitamab (drug)
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
178
Started
2024-12-05
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-hodgkin lymphoma, b-cell
  • • Phase2 - 178 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-hodgkin lymphoma, b-cell

Where?

  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • Manchester - The Christie NHS Foundation Trust
  • • Plymouth - Plymouth Hospitals NHS Trust
  • • Sutton - The Royal Marsden Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Non-Hodgkin Lymphoma, B-cell

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD3CD20

What the study is looking for

  • ✓Age ≥18 years old
  • ✓Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed...
  • ✓At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT...
  • ✓Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)
  • ✓Life expectancy of ≥12 weeks.

Who cannot take part

  • ✗Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
  • ✗Concurrent participation in another therapeutic clinical study.
  • ✗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
See the full 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.

Where Is This Study? (5 UK sites)

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Mark Rafferty, DrPrincipal Investigator

The Christie NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)
Kim Linton, DrPrincipal Investigator

Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

Recruiting
Site contact (verified)
David Burns, DrPrincipal Investigator

The Royal Marsden Hospital

Sutton, United Kingdom

Recruiting
Site contact (verified)
David Cunningham, DrPrincipal Investigator

St George's Hospital

Tooting, United Kingdom

Recruiting
Site contact (verified)
Ruth Pettengell, DrPrincipal Investigator

How to Get in Touch

Head of Clinical Operations

Sponsor contact

CONTACT

+48 123140200 clinicaltrials@ryvu.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09