Ongoing Clinical Trials for B-cell Lymphoma Refractory

There are currently 10 ongoing clinical trials investigating new treatments for patients with B-cell lymphoma refractory, a condition where the cancer does not respond to standard treatments. These trials are taking place across multiple countries in Europe and are testing various innovative therapies, including CAR T-cell therapies and bispecific antibodies, aimed at improving outcomes for patients whose disease has not responded to conventional treatments.

Clinical trial locations

Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies

This trial focuses on long-term follow-up for patients who have previously received Miltenyi CAR T-cell therapy for various B-cell malignancies, including relapsed or refractory cases. To participate, patients must have received the therapy at least 12 months prior and provide informed consent. The study includes both adult and pediatric patients who have been treated for conditions such as acute lymphoblastic leukemia and non-Hodgkin lymphoma.

The main goal of this study is to evaluate the long-term safety of these innovative cell therapies. Participants will undergo regular monitoring to check for late-onset side effects, serious health events, new or returning cancers, and other significant health issues. The study also tracks B and T lymphocyte counts and checks for any remaining modified cells from the therapy.

Patients who are pregnant or breastfeeding, have other unspecified types of cancer, or are currently participating in another clinical trial cannot join this study. The follow-up period is designed to last until December 31, 2040, providing valuable long-term safety data.

The investigational therapy used is Miltenyi CAR T Cell Therapy, which involves genetically modifying a patient’s own immune cells to better recognize and attack cancer cells.

Study on MB-CART2219.1 for Adults and Children with Relapsed or Refractory B-cell Malignancies

This study is testing MB-CART2219.1, a new cell therapy designed to target CD19 and CD22 proteins found on the surface of cancer cells. The therapy is for patients whose B-cell malignancies have returned or not responded to previous treatments. Both adults and children can participate, with specific age requirements depending on the type of cancer.

To join, patients must have relapsed or refractory lymphoma (18 years or older) or acute lymphoblastic leukemia (12 years or older). The cancer cells must show CD19 or CD22 markers. Participants must agree to use effective birth control during the study and for 12 months after treatment. Women must have negative pregnancy tests throughout the study.

Patients younger than 3 years old or whose cancer cells do not have CD19 or CD22 markers cannot participate. The treatment is given through an intravenous infusion, and participants will be monitored for side effects and effectiveness over time, with follow-up continuing for up to 15 years.

The investigational drug is MB-CART2219.1, a modified cell therapy that helps the immune system recognize and attack cancer cells.

Study on the Safety and Effectiveness of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

This trial is testing Glofitamab, a special protein designed to help the immune system target and destroy cancer cells, in combination with Obinutuzumab. The study is for patients whose B-cell non-Hodgkin’s lymphoma has returned or not responded to at least two previous treatments.

Participants must be willing to follow the study’s requirements, including hospital stays. They must have adequate liver, blood, and kidney function, a life expectancy of at least 12 weeks, and measurable disease. The study is open to both male and female patients with good performance status, meaning they can carry out light work or are fully active.

Patients who are pregnant, breastfeeding, have other serious health conditions that could interfere with the study, are unable to follow study procedures, or have participated in another recent clinical trial cannot join. The treatment involves intravenous infusions, with Obinutuzumab given first as a pre-treatment, followed by Glofitamab.

The investigational drugs are Glofitamab, which targets specific proteins on cancer cells, and Obinutuzumab, which helps the immune system attack cancer cells.

Study on the Safety and Effectiveness of MB-CART2019.1, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory B Cell Neoplasms

This study focuses on children and adolescents with mature B-cell neoplasms that have returned or not responded to initial treatment. The trial tests MB-CART2019.1, a cell therapy that modifies a patient’s own immune cells to fight cancer more effectively.

To participate, children must be between 6 months and less than 18 years old, weigh at least 6 kilograms, and have measurable disease. They must have received standard chemotherapy previously and have adequate bone marrow and organ function. Patients and guardians must provide consent, and those who are sexually active must agree to use effective birth control.

Before receiving MB-CART2019.1, patients undergo a preparatory treatment with fludarabine and cyclophosphamide to prepare the body. The cell therapy is then given through intravenous infusion. Additional supportive medications, including tocilizumab, may be used to manage side effects.

Patients who have not experienced disease return or have not tried previous treatments cannot participate. The study includes long-term follow-up to monitor lasting effects.

The investigational drug is MB-CART2019.1, a modified cell therapy targeting CD19 and CD20 proteins on cancer cells.

Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

This study is testing Epcoritamab, a bispecific antibody, in combination with various anti-cancer drugs for patients with B-cell non-Hodgkin’s lymphoma. The trial aims to determine the best dose of Epcoritamab and evaluate its safety when used with medications including lenalidomide, prednisolone, cyclophosphamide, rituximab, ibrutinib, venetoclax, doxorubicin hydrochloride, and polatuzumab vedotin.

To join, participants must be at least 18 years old with confirmed diffuse large B-cell lymphoma that is CD20-positive. They must have measurable disease and an ECOG performance status of 0 to 2, meaning they can perform daily activities with some limitations. At least one measurable tumor larger than 1.5 cm must be present.

Patients who are pregnant, breastfeeding, unable to safely receive the study medications, or have participated in another recent trial cannot join. The treatment involves multiple phases, with different combinations of medications given through intravenous infusions or oral administration. Regular monitoring assesses safety and effectiveness throughout the study.

The main investigational drug is Epcoritamab, which engages the immune system to target cancer cells, combined with various standard cancer-fighting medications.

Study on the Safety and Effectiveness of MB-CART2019.1 for Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

This trial studies MB-CART2019.1, a genetically engineered cell therapy, for patients whose diffuse large B cell lymphoma has returned or not responded to at least two previous treatments. The modified cells are designed to recognize CD19 and CD20 proteins on cancer cells.

Participants must be 18 years or older with confirmed DLBCL, have tried at least two previous therapies, and have good general health status. They must have measurable disease, adequate kidney and heart function, proper liver function, and sufficient blood cell counts. Patients must have a life expectancy greater than 3 months and agree to use birth control during the study.

Before receiving MB-CART2019.1, patients undergo a conditioning treatment with cyclophosphamide and fludarabine to reduce existing immune cells. The cell therapy is then given through intravenous infusion. Some participants may receive a placebo for comparison. Regular health assessments, including imaging tests, track treatment progress and response.

Patients who have not failed at least two previous treatments or are not within the specified age range cannot participate. The study monitors overall response rates, duration of response, progression-free survival, and overall survival.

The investigational drug is MB-CART2019.1, a CAR T-cell therapy targeting CD19 and CD20 on cancer cells.

Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

This study is testing Epcoritamab (also called GEN3013) for patients with B-cell lymphoma that has returned, worsened, or not responded to treatment. The trial aims to find the best dose and evaluate how well it works. Epcoritamab is given through subcutaneous injections under the skin.

To participate, patients must be 18 years or older (21 in some countries), have confirmed CD20-positive mature non-Hodgkin B-cell lymphoma that has returned or worsened after treatment with an anti-CD20 antibody, and have received at least two previous treatments. They must have measurable disease and an ECOG performance status of 0, 1, or 2.

The study is conducted in phases, starting with dose-escalation to find the safest and most effective dose, then expanding to evaluate effectiveness. Some participants may receive a placebo. Additional medications such as paracetamol, dexamethasone, and tocilizumab may be used to manage symptoms and side effects, particularly Cytokine Release Syndrome.

Patients without lymphoma of B-cell origin, those outside the specified age range, or those not meeting other health criteria cannot participate. The study runs until February 2028, gathering information on long-term effects.

The investigational drug is Epcoritamab (GEN3013), a monoclonal antibody targeting specific proteins on cancer cells.

Study on MB-CART2019.1 for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Not Eligible for High-Dose Chemotherapy and Stem Cell Transplantation

This trial compares MB-CART2019.1 with standard R-GemOx treatment (rituximab, gemcitabine, and oxaliplatin) for patients with relapsed or refractory diffuse large B-cell lymphoma who cannot receive high-dose chemotherapy and stem cell transplantation. The study aims to determine if the new treatment helps patients live longer without disease progression.

Participants must be at least 18 years old with confirmed DLBCL based on WHO classification. They must have relapsed or refractory disease after first-line chemoimmunotherapy that included anthracycline-based treatment and rituximab. Patients must have measurable disease on PET scan, a life expectancy greater than 3 months, and be unable to receive high-dose chemotherapy followed by stem cell transplantation. Tumor tissue samples must be available for confirmation.

Patients who are eligible for high-dose chemotherapy and stem cell transplantation, are pregnant or breastfeeding, or cannot follow study procedures cannot participate. Participants are randomly assigned to receive either MB-CART2019.1 or the standard combination therapy. Regular monitoring assesses response and side effects, with follow-up continuing until March 2030.

The investigational drugs are MB-CART2019.1, a modified cell therapy, compared with standard treatments including rituximab, gemcitabine, and oxaliplatin.

Study on Tafasitamab with Gemcitabine, Oxaliplatin, and Rituximab for Patients with Aggressive B-cell Lymphoma

This study is investigating a combination of medications for aggressive B-cell lymphoma that has relapsed or not responded to treatment. The treatment includes gemcitabine, oxaliplatin, rituximab, and tafasitamab (also known as MOR208), all given through intravenous infusion.

To join, patients must have a confirmed diagnosis of certain types of B-cell lymphoma, have received previous treatments (at least one but no more than two), be 18 years or older, and have adequate bone marrow, liver, and kidney function. They must have at least one measurable tumor or bone marrow involvement and provide informed consent. Adequate contraception is required if needed, and patients must have a certain level of physical ability unless the condition is expected to improve with treatment.

Patients with different types of cancer than malignant B-cell lymphoma, those outside the age range, or those considered part of vulnerable populations not specified for the study cannot participate. The treatment is structured in cycles, with the goal of achieving a response within the first eight cycles. Regular monitoring tracks progress, response rates, progression-free survival, overall survival, and quality of life.

The investigational drugs include gemcitabine, oxaliplatin, rituximab, and tafasitamab (MOR208), working together to attack cancer cells.

Study on the Safety and Effectiveness of Mosunetuzumab and Atezolizumab for Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

This trial is testing Mosunetuzumab, a protein that targets cancer cells, for patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia that has returned or not responded to at least two previous treatments. In some parts of the study, Mosunetuzumab is used alone, while in others it is combined with Atezolizumab.

To participate, patients must provide tumor samples and have an ECOG performance status of 0 or 1, with a life expectancy of at least 12 weeks. They must have confirmed relapsed or refractory non-Hodgkin’s lymphoma or chronic lymphocytic leukemia with expected CD20 expression and no other available treatment to improve survival. For non-Hodgkin’s lymphoma patients, at least one measurable tumor larger than 1.5 cm must be present. Adequate liver, blood, and kidney function are required.

Patients with different types of cancer, those who have not failed at least two previous treatments, or those unable to safely tolerate the medications cannot participate. Mosunetuzumab can be given as a subcutaneous injection under the skin or as an intravenous infusion. When combined with Atezolizumab, both are given through infusion. The study monitors how the body processes the medication and evaluates safety, effectiveness, and optimal dosing.

The investigational drugs are Mosunetuzumab, which engages the immune system to target cancer cells, and Atezolizumab, which helps the immune system attack cancer cells.

Summary

These 10 ongoing clinical trials represent significant advances in treating B-cell lymphoma refractory, offering hope to patients whose disease has not responded to conventional treatments. The trials are distributed across multiple European countries, with Germany hosting the most studies (8 trials), followed by France and Spain (5 trials each), and the Netherlands, Italy, and Poland (4 trials each). Other participating countries include Belgium, Czechia, Denmark, Finland, Sweden, Austria, Hungary, Lithuania, and Croatia.

The trials focus on innovative therapies, particularly CAR T-cell therapies and bispecific antibodies. Several studies are testing variations of MB-CART therapies, which modify patients’ own immune cells to target cancer. These include MB-CART2019.1, which targets both CD19 and CD20 proteins on cancer cells, and MB-CART2219.1, targeting CD19 and CD22. Bispecific antibodies like Epcoritamab, Glofitamab, and Mosunetuzumab are also being studied extensively, either alone or in combination with other treatments.

Most trials are designed for adult patients, though some studies specifically include children and adolescents with relapsed or refractory disease. Common eligibility criteria include having received at least two previous lines of therapy, having measurable disease, and maintaining adequate organ function. Many trials exclude patients who are eligible for high-dose chemotherapy and stem cell transplantation, focusing instead on those who have exhausted standard treatment options.

The diverse range of treatments being studied, from cell therapies to antibody combinations with chemotherapy, reflects the complexity of treating refractory B-cell lymphomas and the commitment to finding more effective options for these challenging cases. Patients interested in participating should discuss eligibility with their healthcare providers, as each trial has specific requirements regarding disease type, previous treatments, and overall health status.

#1 Clinical Trials Search in Europe

B-cell lymphoma refractory – Trials in Disease

Ongoing Clinical Trials for B-cell Lymphoma Refractory

Clinical trial locations

Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies

Study on MB-CART2219.1 for Adults and Children with Relapsed or Refractory B-cell Malignancies

Study on the Safety and Effectiveness of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

Study on the Safety and Effectiveness of MB-CART2019.1, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory B Cell Neoplasms

Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

Study on the Safety and Effectiveness of MB-CART2019.1 for Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

Study on MB-CART2019.1 for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Not Eligible for High-Dose Chemotherapy and Stem Cell Transplantation

Study on Tafasitamab with Gemcitabine, Oxaliplatin, and Rituximab for Patients with Aggressive B-cell Lymphoma

Study on the Safety and Effectiveness of Mosunetuzumab and Atezolizumab for Patients with Relapsed or Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia

Summary

Ongoing Clinical Trials on B-cell lymphoma refractory

Study of valemetostat tosylate tablets in patients with relapsed or refractory B-cell lymphoma, including aggressive B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and Hodgkin lymphoma

Study on the Safety and Effectiveness of MB-CART2019.1, Fludarabine, and Cyclophosphamide in Children with Relapsed or Refractory B Cell Neoplasms

Study on the Safety and Tolerability of Epcoritamab with Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

Long-Term Safety Study of MB-CART19.1, MB-CART20.1, and Zamtocabtagene Autoleucel for Patients with Advanced Melanoma or B-Cell Malignancies

Study on UCART20x22 for Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Using a Drug Combination

Study on the Safety and Effectiveness of MB-CART2019.1 for Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma

Study on Tafasitamab with Gemcitabine, Oxaliplatin, and Rituximab for Patients with Aggressive B-cell Lymphoma

Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

Study on the Safety and Effects of Englumafusp Alfa with Obinutuzumab and Glofitamab for Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Study of Axi-Cel, Fludarabine Phosphate, and Cyclophosphamide for Patients with Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma Ineligible for Stem Cell Transplant

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B-cell lymphoma refractory – Trials in Disease

Ongoing Clinical Trials for B-cell Lymphoma Refractory

Clinical trial locations

Summary

Ongoing Clinical Trials on B-cell lymphoma refractory

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