Ongoing Clinical Trials for Recurrent Mantle Cell Lymphoma
Currently, there are 3 ongoing clinical trials investigating treatments for mantle cell lymphoma that has returned after previous treatment. These trials are testing innovative therapies including combination drug treatments, CAR-T cell therapy, and antibody-drug conjugates. The studies are taking place in Italy, Germany, and Poland, offering patients different treatment approaches depending on their previous therapies and current health status.
Clinical trial locations
- Germany
- Italy
- Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
- Study on KTE-X19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Mantle Cell Lymphoma Responding Partially to Ibrutinib
- Study on Loncastuximab Tesirine for Patients with Relapsed or Refractory Mantle Cell Lymphoma After Immunochemotherapy with Rituximab, Bendamustine, and Cytarabine
- Poland
Study of BGB-16673 in combination with drug therapy for patients with relapsed or refractory B-cell malignancies
This trial is testing BGB-16673, an experimental medication that works differently from standard treatments. Instead of just blocking a protein called BTK, it actually breaks it down. The medication is being studied in combination with other drugs including zanubrutinib, sonrotoclax, mosunetuzumab, obinutuzumab, and glofitamab.
Who can participate: Adults aged 18 and older with confirmed B-cell cancers that have returned or not responded to previous treatment. You must be able to perform daily activities with minimal limitations and have adequate organ function, including kidney function with an eGFR of at least 30 or 50 mL/min depending on the treatment group. Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting treatment.
Who cannot participate: People under 18 years old, those with active cancer involvement in the central nervous system, anyone with serious heart problems or uncontrolled infections, pregnant or breastfeeding women, and those with active HIV, hepatitis B, or hepatitis C infections. The trial also excludes people who have had major surgery within 4 weeks or have other serious medical conditions that could make participation unsafe.
What the study focuses on: The trial will determine the right doses of these drug combinations and evaluate how well they work together. Researchers will monitor how many patients respond to treatment, how long the response lasts, and what side effects occur. Some patients will also have tests to measure remaining cancer cells in their blood or bone marrow.
Investigational drugs: The main medication is BGB-16673, a BTK-degrader that breaks down proteins important in B-cell cancers. It will be combined with various other medications given either as tablets by mouth or through infusions into a vein or injections under the skin.
Study on KTE-X19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Mantle Cell Lymphoma Responding Partially to Ibrutinib
This study is investigating KTE-X19, a type of CAR-T cell therapy that uses your own immune cells, modified to better recognize and attack cancer cells. The treatment is specifically for patients who are currently taking ibrutinib and whose disease has partially responded but not completely disappeared.
Who can participate: Adults between 18 and 75 years old with confirmed mantle cell lymphoma that has returned or not responded to at least one previous treatment. You must currently be taking ibrutinib without problems tolerating it and have shown a partial response after at least 6 months of treatment. You must have a life expectancy of at least 12 weeks, be fully active or have only some symptoms without needing bed rest during the day, and have adequate blood counts and organ function. Women who can become pregnant must have a negative pregnancy test and use effective birth control.
Who cannot participate: Patients who have not experienced a return or worsening of their condition, those not currently receiving ibrutinib as a single therapy, those not in partial remission during ibrutinib therapy, and those unable to receive the KTE-X19 infusion.
What the study focuses on: The trial will evaluate how effective KTE-X19 therapy is after patients have shown a partial response to ibrutinib. The study will assess complete response rates at 90 days after the infusion and continue monitoring at 180 days and 365 days to evaluate long-term effectiveness and safety.
Investigational drugs: KTE-X19 is a CAR-T cell therapy where your immune cells are collected, modified in a laboratory to better attack cancer cells, and then returned to your body through an infusion. Before receiving KTE-X19, patients will receive cyclophosphamide and fludarabine chemotherapy to prepare the body for the cell therapy. Ibrutinib, a medication that blocks a protein cancer cells need to grow, continues to be used as part of the treatment approach.
Study on Loncastuximab Tesirine for Patients with Relapsed or Refractory Mantle Cell Lymphoma After Immunochemotherapy with Rituximab, Bendamustine, and Cytarabine
This trial is studying loncastuximab tesirine, an antibody-drug conjugate that combines an antibody with a cancer-fighting drug to specifically target and destroy cancer cells. The treatment is used as consolidation therapy after initial treatment with rituximab, bendamustine, and cytarabine.
Who can participate: Adults between 18 and 84 years old with confirmed mantle cell lymphoma according to WHO classification. You must have relapsed or refractory disease after one to four previous treatments and must have been previously treated with Bruton Tyrosine Kinase inhibitors or stopped this treatment due to side effects. You should be either new to bendamustine treatment or have relapsed at least one year after last receiving it. You must have measurable disease that is at least 1.5 cm in the longest diameter, have a life expectancy of at least 3 months, and have adequate kidney and liver function.
Who cannot participate: Patients who have not been treated with BTK inhibitors or are not intolerant to them, those who have not experienced a return or worsening after previous treatment, and those who have not received two courses of rituximab-bendamustine-cytarabine treatment.
What the study focuses on: The trial aims to assess how long patients can go without their disease getting worse after receiving loncastuximab tesirine following initial treatment with rituximab, bendamustine, and cytarabine. Researchers will also monitor overall survival, improvement or stabilization rates, and any side effects that occur.
Investigational drugs: Loncastuximab tesirine is the main medication being studied, given through an intravenous infusion. It works by binding to a specific protein on cancer cells and delivering a toxic payload that disrupts their DNA, leading to cell death. The initial treatment phase includes rituximab, bendamustine, and cytarabine, all given intravenously, before the consolidation treatment with loncastuximab tesirine begins.
Summary
These three clinical trials represent different approaches to treating recurrent mantle cell lymphoma. Italy stands out as the only country hosting all three trials, making it a significant center for research in this area. Germany and Poland each participate in one trial focused on B-cell malignancies.
The trials reflect the evolution of cancer treatment strategies. One study explores combination drug therapy with BGB-16673, a novel BTK-degrader. Another investigates CAR-T cell therapy, which harnesses the patient’s own immune system. The third examines antibody-drug conjugates that deliver targeted treatment directly to cancer cells.
An interesting pattern emerges regarding previous treatments. Two of the trials specifically focus on patients who have been treated with or are intolerant to BTK inhibitors, highlighting the need for effective alternatives when standard treatments stop working. The CAR-T cell therapy trial takes a unique approach by enrolling patients who are currently responding partially to ibrutinib, attempting to improve upon this partial response.
Each trial has different eligibility requirements, particularly regarding kidney function, previous treatments, and disease status. This variety means that patients at different stages of their treatment journey may find suitable options among these studies. However, all trials require adequate organ function and exclude patients with serious infections or other severe medical conditions.
