Actively Recruiting
MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
Led by Ryvu Therapeutics SA · Updated on 2025-09-29
178
Participants Needed
36
Research Sites
103 weeks
Total Duration
On this page
Sponsors
R
Ryvu Therapeutics SA
Lead Sponsor
M
Menarini Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma
- Relapsed or refractory disease with at least 2 prior systemic treatments
- Nafve to anti-CD3xCD20 bispecific antibody treatment (group 1) or exhausted all standard treatment options (group 2)
- At least 1 measurable disease site on CT or PET-CT scan involving 2 or more clearly defined lesions or nodes
- Availability of lymph node tissue at screening or archival sample (part 2 participants only)
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
- Adequate organ and hematologic function at screening
You will not qualify if you...
- Primary central nervous system lymphoma or CNS involvement at screening
- Received anti-cancer treatments including chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 days or 5 half-lives before study drug
- Prior CAR-T cell or anti-CD3xCD20 bispecific antibody therapy (except for group 2) without at least 4 weeks washout
- Concurrent participation in another therapeutic clinical study
- Ongoing significant toxicity from prior anti-cancer therapy not resolved to Grade 1 or less
- Prior treatment with a PIM inhibitor
- Group 1 only: prior therapy with bispecific antibody targeting CD3 and CD20
- Known allergy risk to MEN1703 or glofitamab or their components
- Contraindication to all uric acid lowering agents
- Major surgery within 1 month prior to first dose
- Hematopoietic stem cell transplant within 4 months prior to first dose
- Requires systemic immune-modulating therapy or has autoimmune or immunosuppressive disease
- Exposure to live or live attenuated vaccines within 4 weeks prior to consent
- Ongoing uncontrolled infections except mild improving infections
- Known HIV infection
- Current active liver disease
- Ongoing drug-induced pneumonitis
- Ongoing inflammatory bowel disease
- Active known second malignancy
- Recent use of CYP2D6 or BCRP interacting agents within 14 days or 5 half-lives
- Cardiac dysfunction including recent myocardial infarction, severe heart failure, arrhythmias, or poorly controlled angina
- Active thromboembolic event treatment (except prophylaxis)
- History of serious ventricular arrhythmia or prolonged QT interval
- Conditions affecting oral drug intake
- Planning pregnancy or breastfeeding during and 1 month after treatment
- Any other condition that may jeopardize safety or study objectives per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Centre Hospitalier Le Mans
Le Mans, France, 72037
Actively Recruiting
2
CHU de Lille - Hôpital Claude Huriez
Lille, France
Actively Recruiting
3
CHU de Limoges - CHU Dupuytren
Limoges, France, 87042
Actively Recruiting
4
Hospices Civils De Lyon - Hôpital Lyon Sud
Lyon, France, 69310
Actively Recruiting
5
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France, 34490
Actively Recruiting
6
APHP - Hôpital Pitié-Salpêtrière
Paris, France, 75651
Actively Recruiting
7
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33600
Actively Recruiting
8
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
Biała Podlaska, Poland
Actively Recruiting
9
IN-VIVO Bydgoszcz Sp. z o.o.
Bydgoszcz, Poland
Actively Recruiting
10
Klinika Hematologii I Transplantologii Uck
Gdansk, Poland
Not Yet Recruiting
11
Szpitale Pomorskie Sp. z o.o.
Gdynia, Poland
Actively Recruiting
12
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy
Gliwice, Poland
Actively Recruiting
13
Pratia Hematologia Sp. z o.o.
Katowice, Poland
Actively Recruiting
14
Pratia MCM Kraków
Krakow, Poland
Actively Recruiting
15
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Not Yet Recruiting
16
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Actively Recruiting
17
Aidport Sp. z o.o.
Skórzewo, Poland
Actively Recruiting
18
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland
Actively Recruiting
19
Lux Med Onkologia Sp. z o.o.
Warsaw, Poland
Actively Recruiting
20
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw, Poland
Actively Recruiting
21
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
22
Clinica Universidad De Navarra
Madrid, Spain, 28027
Actively Recruiting
23
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
24
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Not Yet Recruiting
25
Hospital Clínico Uni versitario Virgen de la Arrixaca
Murcia, Spain, 30120
Not Yet Recruiting
26
Clinica Universidad De Navarra
Pamplona, Spain, 31008
Actively Recruiting
27
Hospital Universitario De Navarra
Pamplona, Spain, 31008
Actively Recruiting
28
Hospital Universitario De Salamanca
Salamanca, Spain, 37007
Actively Recruiting
29
Hospital Universitario Virgen De La Macarena
Seville, Spain, 41009
Actively Recruiting
30
Hospital Universitario Miguel Servet
Zaragoza, Spain
Not Yet Recruiting
31
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
32
The Royal Marsden Hospital
London, United Kingdom
Not Yet Recruiting
33
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
34
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
Actively Recruiting
35
The Royal Marsden Hospital
Sutton, United Kingdom
Not Yet Recruiting
36
St George's Hospital
Tooting, United Kingdom
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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