Academisch Ziekenhuis Leiden
Leiden, The Netherlands
Not recruitingRare disease
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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- 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 trial?
7 criteria
- 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.
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Responsive Responsive Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, BelgiumResponsive Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Trial locations
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Investigated drugs
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.
What is already known about the treatment
GLPG5101 – GLPG5101 is administered as a treatment for individuals with relapsed or refractory B-cell non-Hodgkin lymphoma, a type of cancer affecting the lymphatic system. This medication is currently being studied in clinical trials to assess its safety and effectiveness, with the goal of determining the appropriate dosage and its impact on different subtypes of this lymphoma. GLPG5101 works at the molecular level by targeting specific cancer cells, helping to stop their growth and spread. It falls under the pharmacological classification of targeted cancer therapies, which are designed to interfere with cancer cell growth mechanisms.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2022-502661-23-00Protocol codeCP0201-NHLEstimated enrolment215 patientsSponsorGalapagos
sourced from the EU Clinical Trials Register and site verification
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