Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma. The study will explore the effects of a medication called MEN1703, both on its own and in combination with another medication named Glofitamab. MEN1703 is available in capsule form, while Glofitamab is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients who have not responded to previous therapies or whose cancer has returned.

The study will be conducted in different parts. Initially, the safety and tolerability of MEN1703 alone and in combination with Glofitamab will be assessed. This means researchers will monitor how well patients tolerate the medications and any side effects that may occur. Following this, the study will focus on the ability of these treatments to fight the lymphoma, which is a type of cancer that affects the lymphatic system, a part of the body’s immune system. The study will involve regular monitoring and assessments to track the progress and response of the cancer to the treatments.

Participants in the study will receive either the combination of MEN1703 and Glofitamab or MEN1703 alone. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study aims to provide valuable information on the potential benefits and risks of these treatments for patients with this challenging form of lymphoma. The trial is expected to continue until the end of 2026, with recruitment starting in late 2024.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

A series of tests and evaluations are performed to ensure all criteria are met, such as blood tests and imaging scans.

2 group assignment

Participants are assigned to one of two groups. Group 1 receives a combination of MEN1703 and glofitamab, while Group 2 receives MEN1703 alone.

The assignment is based on specific criteria and study requirements.

3 treatment initiation

Treatment begins with the administration of the assigned medication. MEN1703 is taken orally in capsule form, with dosages of 100 mg and 25 mg.

For Group 1, glofitamab is administered through an intravenous infusion. The dosage and frequency are determined by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes routine blood tests and health evaluations.

Participants attend scheduled follow-up visits to track progress and address any side effects or concerns.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the medication.

Participants may be asked to provide feedback on their experience and any changes in their health condition.

Who Can Join the Study?

Must be at least 18 years old.
Must have a life expectancy of at least 12 weeks.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2, which is a scale used to assess how a disease affects daily living abilities.
Must have adequate organ function, including:
- Liver function: AST or ALT levels no more than 2.5 times the normal limit, and total bilirubin no more than 1.5 times the normal limit. Patients with Gilbert’s Syndrome are eligible if certain conditions are met.
- Kidney function: Serum creatinine no more than 1.5 times the normal limit or a creatinine clearance of at least 50 mL/min.
- Heart function: Left ventricular ejection fraction (LVEF) of at least 40%.
Must have adequate blood cell counts, including:
- Lymphocyte count: Less than 5.0 x 10⁹/L.
- Platelet count: At least 75 x 10⁹/L, or at least 50 x 10⁹/L if there is bone marrow involvement or splenomegaly, without recent platelet transfusion.
- Hemoglobin: At least 10.0 g/dL, without recent blood transfusion.
- Absolute neutrophil count (ANC): At least 1.0 x 10⁹/L, with growth factor support allowed.
Must be capable of providing informed consent.
Must have normal blood clotting parameters, with PT/INR and PTT less than 1.5 times the normal limit.
Women of childbearing potential must have a negative pregnancy test at screening and within 3 days of the first dose of the drug.
Must agree to use highly effective contraceptive methods during treatment and for 1 month after stopping the study drug. This applies to both men and women of childbearing potential.
Must agree not to donate blood, eggs, or sperm during the study and for 1 month after the last dose of the study drug.
Must have a confirmed diagnosis of aggressive B-cell non-Hodgkin lymphoma, including DLBCL NOS and transformed indolent B-cell lymphoma.
Must have relapsed or refractory disease after at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma.
Must have at least one measurable site of disease based on CT or PET-CT scan.
For Part 2 participants only: Must have lymph node tissue available at screening suitable for testing, with archival samples allowed if they meet certain conditions.

Who Cannot Join the Study?

Patients with any other type of cancer that is not the specific type being studied, which is Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma.
Patients who have had a recent heart attack or have severe heart problems.
Patients with uncontrolled infections.
Patients who are pregnant or breastfeeding.
Patients who have had an organ transplant.
Patients who are currently participating in another clinical trial.
Patients with a history of severe allergic reactions to similar medications.
Patients with severe liver or kidney disease.
Patients with a history of drug or alcohol abuse.
Patients who have received certain treatments for their lymphoma within a specific time frame before the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario De Navarra	Pamplona	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Szpitale Pomorskie Sp. z o.o.	Gdynia	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
MD Anderson Cancer Center	Madrid	Spain
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Centre Hospitalier Et Universitaire De Limoges	Limoges	France
Centre Hospitalier Le Mans	Le Mans	France
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Pratia S.A.	Skorzewo	Poland
In Vivo Sp. z o.o.	Bydgoszcz	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Cracow	Poland
Lux Med Onkologia Sp. z o.o.	Warsaw	Poland
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hospital Vall d’Hebron	Barcelona	Spain
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Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Akzvomb Sbb z opqz	Poznan	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.11.2024
Poland	Recruiting	01.11.2024
Spain	Recruiting	01.11.2024

Trial locations

Investigated drugs:

MEN1703 is a medication being tested in this clinical trial. It is being studied both on its own and in combination with another medication. The main goal of using MEN1703 is to see how well it works against a type of cancer called aggressive B-cell non-Hodgkin lymphoma, which is a cancer of the lymphatic system. Researchers are also looking at how safe and tolerable MEN1703 is for patients, meaning they want to know if it causes any side effects and how patients feel while taking it.

Glofitamab is another medication involved in this trial. It is used in combination with MEN1703 to see if the two medications together can better fight the aggressive B-cell non-Hodgkin lymphoma. Glofitamab is designed to help the body’s immune system target and destroy cancer cells. The trial aims to understand how effective this combination is in treating the cancer and to ensure that it is safe for patients to use.

Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. It is characterized by the rapid growth of malignant cells in the lymph nodes, spleen, or other organs. The disease is termed “relapsed” when it returns after treatment and “refractory” when it does not respond to standard treatments. As the disease progresses, it can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The aggressive nature of this lymphoma means it can spread quickly to other parts of the body. The progression of the disease can vary, with some cases advancing rapidly while others may progress more slowly.

Trial ID:

2024-513098-31-00

Protocol code:

JASPIS-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?