Study on the Safety and Effectiveness of 19CP02 for Patients with Relapsed or Refractory 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 non-Hodgkin lymphoma, specifically in cases where the disease has returned or has not responded to previous treatments. The study is testing a new treatment called GLPG5101, also known by its code name 19CP02. This treatment is a form of cell therapy, which involves using specially modified cells to target and fight the cancer. The cells used in this therapy are called T cells, which are a type of immune cell that can be engineered to better recognize and attack cancer cells.

The purpose of the study is to evaluate the safety and effectiveness of GLPG5101 in treating non-Hodgkin lymphoma. The study is divided into two phases. In the first phase, the focus is on determining the safety of the treatment and finding the appropriate dose for further testing. The second phase aims to assess how well the treatment works in different subtypes of non-Hodgkin lymphoma. Participants in the study will receive the treatment through an infusion, which means it will be administered directly into the bloodstream.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study will also look at how long the treatment remains effective and how it affects the levels of certain cells and proteins in the body. Some participants may receive a placebo as part of the study design. The study is expected to continue until 2026, with the goal of providing valuable information about the potential benefits and risks of GLPG5101 for patients with non-Hodgkin lymphoma.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.

You must be at least 18 years old and have a confirmed diagnosis of a specific type of non-Hodgkin lymphoma that has returned or not responded to treatment.

2 initial assessment

An initial assessment will be conducted to evaluate your health status. This includes checking your ability to perform daily activities and ensuring your bone marrow, kidney, liver, and lung functions are adequate.

3 treatment administration

You will receive the study medication, GLPG5101 (19CP02), through an intravenous infusion. This means the medication will be given directly into your vein.

The dosage and frequency of the medication will be determined during the study, with the aim of finding the safest and most effective dose.

4 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular check-ups to observe any side effects and to assess how well the treatment is working.

The primary focus in the first phase is to observe any adverse effects until 28 days after the infusion. In the second phase, the effectiveness of the treatment will be evaluated for up to two years.

5 end of participation

Your participation in the study will conclude after the monitoring period, which can last up to two years post-infusion. During this time, the study team will continue to collect data on your response to the treatment.

Who Can Join the Study?

Signed informed consent form: You need to agree to participate in the study by signing a document that explains the study details.
Age: You must be 18 years or older.
Diagnosis: You must have a confirmed diagnosis of one of the following types of non-Hodgkin lymphoma: Aggressive DLBCL, FL grade 1, 2 or 3A, MZL, MCL, BL, or PCNSL.
Relapsed or refractory disease: Your disease must have returned after treatment or not responded to previous treatments.
Measurable disease: Your disease must be measurable according to specific medical guidelines (Lugano classification or IPCG criteria for PCNSL).
ECOG performance status: You must have an ECOG performance status of 0-2. This is a scale that measures your ability to perform daily activities. If your status is 2, your serum albumin (a protein in your blood) must be 3.4 g/dL or higher.
Adequate organ function: Your bone marrow, kidneys, liver, and lungs must be functioning well enough to participate in the study.

Who Cannot Join the Study?

Patients with relapsed/refractory B-cell non-Hodgkin lymphoma cannot participate if they have other types of cancer.
Patients who are not within the specified age range for the study cannot participate.
Patients who are pregnant or breastfeeding are not eligible to participate.
Patients with severe or uncontrolled medical conditions that could interfere with the study are not eligible.
Patients who have participated in another clinical trial within a certain time frame before this study cannot participate.
Patients who have allergies or adverse reactions to the study medication or similar drugs are not eligible.
Patients who are unable to comply with the study procedures and follow-up requirements cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Centre hospitalier universitaire de Liege	Liege	Belgium
Academisch Medisch Centrum	Amsterdam	The Netherlands
Cfjocmkha Uvnyfdjukatqiu Scsgdqfmp	Woluwe-Saint-Lambert	Belgium
Hrweltvn Uimlpxyjwg Ccwiizn Hgkuyxzp	Helsinki	Finland
Ebypkgl Uvbdtqapnmxe Mssgxdo Ciuxikv Rcywtezmv (eyhpmmm Miz	Rotterdam	The Netherlands
Uuunoltfes Oo Aumykex	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.12.2021
Finland	Not recruiting	06.12.2021
The Netherlands	Not recruiting	06.12.2021

Trial locations

GLPG5101 is a new treatment being tested for people with a type of cancer called B-cell non-Hodgkin lymphoma, which has come back or hasn’t responded to other treatments. This therapy is made at the point of care, meaning it is prepared specifically for each patient at the place where they receive their treatment. The study aims to find out if GLPG5101 is safe to use and how well it works in treating this type of cancer. In the first part of the study, researchers are looking to see if there are any side effects and to find the best dose to use in the next phase. In the second part, they will check how effective the treatment is for different subtypes of this lymphoma.

Relapsed/refractory 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. The disease is characterized by the abnormal growth of these B-cells, leading to the formation of tumors in the lymph nodes and other parts of the body. In its relapsed form, the disease returns after treatment, while refractory cases do not respond to standard treatments. The progression involves the spread of cancerous cells to various organs, potentially causing symptoms like swollen lymph nodes, fatigue, and fever. Over time, the disease can lead to complications as it affects the body’s ability to fight infections. The progression and symptoms can vary significantly depending on the specific subtype of non-Hodgkin lymphoma.

Trial ID:

2022-502661-23-00

Protocol code:

CP0201-NHL

NCT ID:

NCT06561425

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety and Effectiveness of 19CP02 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?