JASPIS-01

JASPIS-01

ClinicalTrials.gov ID NCT06534437 

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 

Study population:

Women and man 18 Years and older

Study design:

The study consists of 3 parts, to investigate MEN173 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 at a dose selected from part 2 in combination with glofitamab or glofitamab alone. 

Intervention/treatment:

• Drug: MEN1703 

• Drug: Glofitamab 

 

Eligibility criteria:

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

Exclusion Criteria

• 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. 
• 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. 

 

Participation criteria are verified by the investigator. Participation in the study is contingent upon meeting all inclusion criteria and meeting none of the exclusion criteria. The criteria provided may not be a complete list.   

 

Contact and locations:

Main Researcher	Institution	Address	Phone	Email	Status
Sebastian Grosicki, Prof.	Pratia Hematologia Sp. z o.o., Pratia Onkologia Katowice	Kościuszki 92 40-519 Katowice Poland	+48 587 702 144	[email protected]	not active
Wanda Knopińska-Posłuszny, Phd	Szpitale Pomorskie Sp. z o.o. SZPITAL MORSKI IM. PCK	Powstania Styczniowego 1 81-519 Gdynia Poland	+48 587 260 380	[email protected]	not active
Małgorzata Krawczyk-Kuliś, Phd	Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy, Oddział w Gliwicach, Klinika Transplantacji Szpiku i Onkohematologii	Wybrzeże Armii Krajowej 15 44-102 Gliwice Poland	+48 32 278 85 28 +48 32 278 85 59	Koordynatorzy badania: [email protected] [email protected] Główny Badacz: [email protected]	not active
Janusz Hałka, PhD	Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie	al. Wojska Polskiego 37 10-228 Olsztyn Poland	+48 89 539 87 57	[email protected]	not active
Wojciech Jurczak, Prof.	Pratia MCM Kraków	Pana Tadeusza 2 30-727 Kraków Poland	+48 12 295 41 39 +48 12 295 41 41	[email protected]	not active
Piotr Centkowski, PhD	Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej	Terebelska 57-65 21-500 Biała Podlaska Poland	+48 83 306 77 00	[email protected]	not active
Krzysztof Gawroński, Phd	Wojskowy Instytut Medyczny – Państwowy Instytut Badawczy	Szaserów 128 04-141 Warszawa Poland	+48 26 18 17 013	[email protected]	not active
Dominik Chraniuk, MD PhD	Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu	Św. Józefa 53-39 87-100 Toruń Poland	+48 566 793 745	[email protected]	not active
Joanna Barankiewicz, Phd	Lux Med Onkologia Sp. z o.o. Oddział Hematoonkologii	Szamocka 6 01-748 Warszawa Poland	+48 22 430 87 00	[email protected]	not active