BridgeMD
New treatment option for Non-Hodgkin Lymphoma, B-cell
Official title MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
ClinicalTrials.gov ID: NCT06534437
What this study is testing
What is MEN1703?
MEN1703 is an investigational medicine, being studied as a potential treatment for non-hodgkin lymphoma, b-cell.
Also referred to as SEL24, Dapolsertib hydrochloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)
You likely can't join 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...
- 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...
- Prior treatment with a PIM inhibitor.
- Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Le Mans, France
- Lille, France
- Limoges, France
- Lyon, France
- Montpellier, France
- Paris, France
- Pessac, France
- Biała Podlaska, Poland
- Bydgoszcz, Poland
- Gdansk, Poland
- Gdynia, Poland
- Gliwice, Poland
- Katowice, Poland
- Krakow, Poland
- Olsztyn, Poland
- Skórzewo, Poland
- Torun, Poland
- Warsaw, Poland
- Barcelona, Spain
- Madrid, Spain
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Mans, France; Lille, France; Limoges, France; Lyon, France; Montpellier, France; Paris, France and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.