In short
This article provides information about 2 ongoing clinical trials for patients with cutaneous T-cell lymphoma that has returned after treatment. These trials are testing medications called Lacutamab and Mogamulizumab, and are being conducted in several European countries including France, Spain, Italy, Germany, Poland, and Belgium.
Clinical trial locations
- Belgium
- France
- Germany
- Italy
- Poland
- Spain
Study of Lacutamab Alone or with Chemotherapy for Patients with Advanced T-Cell Lymphoma
This trial is testing a medication called Lacutamab (also known as IPH4102) for patients with advanced forms of cutaneous T-cell lymphoma, including Mycosis Fungoides and Sézary Syndrome. Lacutamab is a type of protein treatment called a monoclonal antibody that targets and attacks cancer cells. The study examines how well Lacutamab works when used alone or combined with chemotherapy.
Who can participate: Patients must be at least 18 years old and have cancer that has returned or not responded to at least two previous treatments. For Sézary Syndrome patients, the cancer must be stage IVA or IVB, and they must have previously tried mogamulizumab. For Mycosis Fungoides patients, the cancer must be stage IB, IIA, IIB, III, or IV. Participants need to have good enough overall health to carry out daily activities with some help (performance status of 2 or less) and must have adequate blood counts, liver function, and kidney function. Women who can become pregnant must use birth control during the study and for 9 months afterward.
Who cannot participate: Patients with other types of cancer that are not the specific T-cell lymphomas being studied cannot join. Those with serious uncontrolled infections, significant heart problems, severe liver or kidney problems, or certain autoimmune diseases are excluded. Pregnant or breastfeeding women, and those who have had severe allergic reactions to similar treatments, cannot participate.
Study focus: The trial evaluates how well patients respond to Lacutamab treatment by measuring the proportion who achieve complete or partial responses. It also monitors safety through regular blood tests, imaging studies, and assessments of side effects. Quality of life is measured using questionnaires, including specific questions about itching. The medication is given as an intravenous infusion, with at least 3 weeks required between any previous treatment and the first dose of Lacutamab.
Investigational drugs: The trial tests IPH4102 (Lacutamab), a medication designed to help the immune system recognize and attack cancer cells by targeting a specific protein on their surface. In some cases, Lacutamab is combined with chemotherapy, which uses drugs to stop cancer cell growth and reduce tumor size.
Study on the Safety of Mogamulizumab for Patients with Relapsed or Refractory Mycosis Fungoides or Sézary Syndrome
This trial is studying the safety of Mogamulizumab (also known as KW-0761 and AMG 761) in patients whose Mycosis Fungoides or Sézary Syndrome has returned or has not responded to previous treatments. The medication is given as an infusion directly into the bloodstream through a vein every four weeks for up to 24 weeks.
Who can participate: Patients must be 18 years or older with a confirmed diagnosis of Mycosis Fungoides or Sézary Syndrome, and must have tried at least one previous treatment that did not work. Eligible treatments include interferon, bexarotene, or chemotherapy (though psoralen plus UVA does not count as a systemic therapy). Participants must be fully active or able to carry out light work (performance status of 0 or 1) and have adequate blood health, liver function, and kidney function. Women who can become pregnant must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after the last dose.
Who cannot participate: Patients with other types of cancer besides Mycosis Fungoides or Sézary Syndrome are excluded. Those currently receiving other cancer treatments, those with serious uncontrolled infections, or those with a history of severe allergic reactions to similar medications cannot join. Pregnant or breastfeeding women are also excluded for safety reasons.
Study focus: The primary goal is to evaluate the safety and tolerability of Mogamulizumab when given every four weeks. Researchers monitor participants for side effects and changes in health through regular physical examinations and laboratory tests. The study also examines how the medication is processed in the body and whether the immune system produces antibodies against it. Regular monitoring continues throughout the treatment period to ensure patient safety.
Investigational drug: Mogamulizumab is a monoclonal antibody administered as an intravenous infusion every four weeks. It works by targeting a specific protein on the surface of certain immune cells, helping the body's immune system attack and destroy cancer cells. This is a type of targeted cancer therapy being studied for its safety and effectiveness in treating relapsed or refractory disease.
Summary
Two clinical trials are currently underway for patients with cutaneous T-cell lymphoma that has returned after treatment. Both trials focus on specific subtypes of the disease: Mycosis Fungoides and Sézary Syndrome. The trials are testing two different monoclonal antibody treatments—Lacutamab and Mogamulizumab—which work by helping the immune system identify and attack cancer cells.
The trial locations show concentration in Western European countries, with France and Spain hosting both trials. The Lacutamab study has a wider geographic reach, including Belgium, Germany, Italy, and Poland in addition to France and Spain. Both studies require patients to have tried previous treatments without success and maintain a certain level of overall health and organ function to participate safely.
These trials represent important research opportunities for patients whose cancer has not responded to standard treatments, offering access to experimental therapies that may provide new treatment options.
