Clinical Trials for Relapsed or Refractory Non-Hodgkin’s Lymphoma
This article provides detailed information about 4 ongoing clinical trials for patients with relapsed or refractory Non-Hodgkin’s lymphoma. These trials are investigating various innovative treatments, including targeted therapies, immunotherapies, and genetically modified T-cell treatments. Trials are currently being conducted in France, Spain, Germany, Poland, and the Netherlands.
Clinical trial locations
- France
- Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
- Study on BMS-986458 and Rituximab for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
- Study on the Safety and Effects of IPH6501 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
- Germany
- Netherlands
- Poland
- Spain
Study of MEN1703 and Glofitamab for Patients with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
This trial is investigating the use of MEN1703, both alone and in combination with glofitamab, for treating aggressive B-cell Non-Hodgkin lymphoma that has not responded to previous treatments or has returned after treatment. The study aims to evaluate the safety, tolerability, and effectiveness of these medications in fighting this challenging form of lymphoma.
Main inclusion criteria: Participants must be at least 18 years old with a life expectancy of at least 12 weeks. They must have confirmed aggressive B-cell Non-Hodgkin lymphoma that has relapsed or not responded to at least two prior lines of treatment. The disease must have at least one measurable site that can be tracked using CT or PET-CT scans. Patients need adequate organ function, including proper liver, kidney, and heart function, as well as acceptable blood cell counts. Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
Main exclusion criteria: The trial excludes patients with other types of cancer, those who have recently had a heart attack or have severe heart problems, uncontrolled infections, pregnancy or breastfeeding, organ transplant recipients, and those currently participating in another clinical trial. Patients with severe liver or kidney disease, a history of severe allergic reactions to similar medications, or a history of drug or alcohol abuse are also excluded.
Study focus: The trial will first assess the safety and tolerability of MEN1703 alone and in combination with glofitamab, monitoring for any side effects. It will then focus on the ability of these treatments to fight the lymphoma and improve patient outcomes. MEN1703 is taken orally in capsule form, while glofitamab is administered through an intravenous infusion. The study aims to gather valuable data on both the benefits and risks of these treatments.
Investigational drugs: MEN1703 works by targeting specific pathways in cancer cells to inhibit their growth and survival. Glofitamab is designed to help the body’s immune system recognize and destroy cancer cells. The combination of these two medications is being tested to see if they work better together than MEN1703 alone.
Study on BMS-986458 and Rituximab for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
This clinical trial is studying BMS-986458, also known as BCL6 Ligand Directed Degrader, both on its own and in combination with other anti-lymphoma medications including rituximab. The study focuses on cases where the disease has returned or has not responded to previous treatments.
Main inclusion criteria: Participants must be 18 years or older with confirmed relapsed or refractory Non-Hodgkin lymphoma, including specific types like Diffuse Large B-Cell Lymphoma and Follicular Lymphoma. Patients with certain subtypes must have had at least two previous treatments. The disease must be measurable, meaning at least one area larger than 1.5 cm that can be seen and measured using imaging tests like CT or MRI scans. All participants must agree to follow a pregnancy prevention plan.
Main exclusion criteria: Patients with a different type of cancer other than the specified types of Non-Hodgkin lymphoma cannot participate. Those not within the specified age range, unable to follow study procedures, with certain medical conditions that might interfere with the study, pregnant or breastfeeding women, and those currently in or recently completed another clinical trial may be excluded. Patients who have had recent major surgery or serious infections may also not be eligible.
Study focus: The trial will evaluate the safety and tolerability of BMS-986458, determining the best dose to use both alone and with other treatments. Researchers will monitor how patients handle the treatment and what side effects might occur. The study will also examine how the body processes the medication and track how well it works by measuring response rates and progression-free survival.
Investigational drugs: BMS-986458 is taken orally as a tablet, while rituximab is given as an intravenous infusion. BMS-986458 targets specific pathways involved in the growth and survival of lymphoma cells, aiming to stop their proliferation.
Study on CD19+ Lymphoid Disease Using Genetically Modified T Cells for Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin’s Lymphoma
This trial uses a special type of treatment called CD19.CAR T cells, which involves modifying a patient’s own immune cells to better recognize and attack cancer cells. The modified cells are then given back to the patient through an infusion directly into the bloodstream.
Main inclusion criteria: For adults aged 18 and older, participants must have a confirmed diagnosis of CD19+ diseases like Acute Lymphoblastic Leukemia or various types of lymphoma, with disease that has returned or not responded to treatment. Kidney function must be adequate with serum creatinine no more than twice the normal limit or an eGFR of at least 30 mL/min/1.73 m². Patients must have at least 100 lymphocytes per cubic millimeter. For children and teenagers older than 3 but younger than 18, they must have CD19+ ALL with returned or resistant disease, measurable disease at enrollment, a life expectancy of at least 12 weeks, adequate performance status, and similar kidney function and lymphocyte count requirements.
Main exclusion criteria: Patients with a different type of cancer than those being studied, those whose cancer has not returned or become resistant to treatment, those not within the specified age range, and members of vulnerable populations that might need special protection cannot participate.
Study focus: The study evaluates the safety and feasibility of using these modified T cells by gradually increasing the dose to find the most effective and safe amount. Researchers will monitor how patients respond and check for any side effects. The trial aims to understand how well the treatment reduces cancer and improves patient outcomes, including looking at the survival and function of the CAR T cells in the body.
Investigational drugs: The treatment uses the RV-SFG.CD19.CD28.4-BBzeta Retroviral Vector to modify T lymphocytes, allowing them to express a special receptor called a CAR that helps them recognize and attack cancer cells with the CD19 molecule on their surface.
Study on the Safety and Effects of IPH6501 for Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
This trial is investigating a new treatment called IPH6501, given as a solution through an infusion into the vein. The study focuses on CD20-expressing Non-Hodgkin lymphoma in patients whose disease has returned or not responded to previous treatments.
Main inclusion criteria: Patients must have CD20-expressing Non-Hodgkin lymphoma that has come back or is not responding to treatment, including specific types like Diffuse Large B Cell Lymphoma, Follicular Lymphoma, and Mantle cell lymphoma. They must have tried at least two different treatments before, including an anti-CD20 antibody like rituximab. Participants must be at least 18 years old with at least one measurable tumor (lymph node more than 1.5 cm or tumor outside lymph nodes more than 1.0 cm). They must have an Eastern Cooperative Oncology Group performance status of 2 or less, a life expectancy of at least 12 weeks, and any side effects from previous treatments must be stable and mild.
Main exclusion criteria: Patients with a different type of cancer that is not CD20-expressing Non-Hodgkin lymphoma, those whose cancer is not relapsed or refractory, those outside the specified age range, those unable to follow study procedures, pregnant or breastfeeding women, and those participating in another clinical trial are excluded. Patients with certain medical conditions, recent treatments that might affect study results, allergies to the study medication, or a history of certain heart, liver, or kidney problems may also be excluded.
Study focus: The trial is conducted in two phases. The first phase tests different doses of IPH6501 to find the safest and most effective dose. The second phase gives the treatment to more patients to further evaluate its safety and potential benefits. Throughout the study, researchers closely monitor patients for side effects and how their cancer responds to the treatment.
Investigational drugs: IPH6501 is designed to target and act against cancer cells that express the CD20 protein. It works by binding to the CD20 protein on the surface of cancer cells, which may help the immune system recognize and destroy these cells.
Summary
These four clinical trials represent diverse approaches to treating relapsed or refractory Non-Hodgkin’s lymphoma. The trials are distributed across several European countries, with France participating in three trials, followed by Spain and Germany with two each, and Poland and the Netherlands with one each.
The studies investigate different treatment strategies, including targeted oral therapies, immunotherapies using monoclonal antibodies, and innovative CAR T-cell therapy involving genetic modification of patients’ own immune cells. Several trials focus on combination approaches, testing new medications alongside established treatments like rituximab and glofitamab.
All trials share common requirements for participation, including confirmed diagnosis with measurable disease, previous treatment history, and adequate organ function. Age requirements vary, with most trials accepting adults 18 and older, though one trial also includes children and teenagers over 3 years old. The expected completion dates range from 2026 to 2028, indicating ongoing recruitment and long-term follow-up to assess both safety and effectiveness of these investigational treatments.
