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B-cell lymphoma recurrent – Trials in Disease

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Ongoing Clinical Trials for B-cell Lymphoma Recurrent

There are currently 6 ongoing clinical trials investigating new treatments for recurrent B-cell lymphoma. These studies are testing innovative cell therapies and antibody-based treatments across multiple countries in Europe, offering hope for patients whose disease has returned or not responded to previous therapies.

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 in Germany focuses on the long-term safety of patients who have previously received Miltenyi CAR T cell therapy for B-cell cancers. It is designed to follow up on individuals who completed their initial treatment at least 12 months ago.

Main inclusion criteria: Patients must have received Miltenyi CAR T cell therapy at least 12 months before joining the study and must provide informed consent. The study is open to both male and female patients across different age groups, including children and adults.

Main exclusion criteria: Patients with other types of cancer not specified in the study, those who have not experienced disease recurrence or worsening, and those not within the specified age range are excluded. Pregnant or breastfeeding patients and those with certain medical conditions that might interfere with the study treatment are also excluded.

Trial focus: The study evaluates the long-term safety of Miltenyi CAR T cell therapy, monitoring patients for late-onset side effects, serious health events, new or returning cancers, and serious infections. Regular follow-up visits will assess participants’ health status through 2040, tracking the presence of modified cells and overall survival rates.

Investigational treatment: Miltenyi CAR T cell therapy uses the patient’s own immune cells, modified in the laboratory to produce chimeric antigen receptors (CARs) on their surface. These modified T cells are then infused back into the patient to enhance the body’s natural ability to fight cancer.

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

This multi-country trial across Belgium, Spain, Poland, France, Finland, Denmark, Czechia, and Italy is testing a combination treatment approach for recurrent lymphoma. The study examines both glofitamab alone and in combination with obinutuzumab.

Main inclusion criteria: Patients must have relapsed or refractory B-cell non-Hodgkin’s lymphoma, including types such as follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, and diffuse large B-cell lymphoma. They must have tried at least two different treatments before, including one with an anthracycline drug and one with CD20-targeted therapy. Patients must have a life expectancy of at least 12 weeks, measurable disease, and good performance status. Both male and female patients are eligible.

Main exclusion criteria: Patients who have not experienced disease return or worsening, those unable to tolerate the study medications, those with other serious health conditions, pregnant or breastfeeding patients, and those unable to follow study procedures are excluded.

Trial focus: The study aims to find the best dose of glofitamab when used alone and combined with obinutuzumab, and to understand how safe and effective these treatments are. Participants receive medications through intravenous infusion, with careful monitoring of response and side effects throughout the study.

Investigational treatments: Glofitamab is a bispecific monoclonal antibody that targets specific proteins on cancer cells to help the immune system attack them. Obinutuzumab is given as pre-treatment to prepare the body for glofitamab, binding to proteins on cancer cells to help the immune system recognize and destroy them.

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

This pediatric trial in France, Germany, Italy, and the Netherlands focuses on children and adolescents with B-cell cancers that have returned after initial treatment or did not respond to first treatment.

Main inclusion criteria: Patients must be children or teenagers between 6 months and less than 18 years old, weighing at least 6 kilograms. They must have a confirmed diagnosis of specific B-cell cancers such as Burkitt lymphoma or diffuse large B-cell lymphoma that has returned or did not respond to treatment. Patients must have measurable disease, adequate bone marrow and organ function, and a performance status score of 60 or higher. Tissue samples must be available for diagnosis confirmation. Sexually active patients must agree to use effective birth control.

Main exclusion criteria: Patients who have not experienced disease return, those who have not tried at least one other treatment, patients not within the specified age range, and those not part of the specified gender groups are excluded.

Trial focus: The study determines how safe and effective MB-CART2019.1 is in treating pediatric B-cell cancers. Patients receive preparatory medications (fludarabine and cyclophosphamide) before the main treatment, followed by close monitoring with regular check-ups at specific intervals (Day 28, Week 8, Week 12, Week 24, Week 52, and Week 78) to assess progress and manage side effects.

Investigational treatment: MB-CART2019.1 is a CAR T-cell therapy that involves modifying the patient’s own immune cells to better recognize and attack cancer cells. The therapy is specifically designed for children with difficult-to-treat B-cell cancers.

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

This trial in Hungary and Croatia focuses specifically on adults with diffuse large B-cell lymphoma whose cancer has returned or has not responded to previous treatments.

Main inclusion criteria: Patients must be 18 years or older with confirmed diffuse large B-cell lymphoma or related subtypes. The disease must have returned or not responded after at least two different treatments, including rituximab and anthracycline. Patients must have good general health (ECOG performance status of 0, 1, or 2 if due to DLBCL), measurable disease, no signs of lymphoma in the central nervous system, adequate kidney function (creatinine clearance greater than 60 mL/min), good heart function (cardiac ejection fraction 45% or higher), and a resting oxygen level greater than 90%. Liver function must be within certain limits, and patients must have adequate white blood cell and platelet counts. Life expectancy must be more than 3 months, and those able to have children must agree to use birth control.

Main exclusion criteria: Patients who have not failed at least two lines of therapy, those whose lymphoma has not returned or is not resistant to treatment, and those not within the specified age range are excluded.

Trial focus: The study evaluates the effectiveness of MB-CART2019.1 in treating diffuse large B-cell lymphoma. Participants first receive a conditioning treatment with cyclophosphamide and fludarabine to prepare the body, followed by a single infusion of MB-CART2019.1. Some participants may receive a placebo for comparison. The trial monitors overall response rate, duration of response, progression-free survival, and overall survival, with regular assessments through imaging tests like MRI.

Investigational treatment: MB-CART2019.1 uses genetically engineered autologous cells designed to express specific receptors targeting CD19 and CD20 proteins on cancer cells, enabling the immune system to attack the lymphoma more effectively.

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 large multi-country trial across France, Germany, Italy, Netherlands, Austria, Spain, Poland, Sweden, Lithuania, Belgium, Czechia, and Hungary compares MB-CART2019.1 with standard R-GemOx treatment for patients who cannot receive high-dose chemotherapy and stem cell transplantation.

Main inclusion criteria: Patients must be at least 18 years old with confirmed diffuse large B-cell lymphoma or related types based on WHO 2016 classification. The disease must have relapsed or been refractory after first-line chemoimmunotherapy that included anthracycline-based treatment and rituximab. Patients must have measurable disease visible on PET scan, life expectancy of more than 3 months, and be considered unable to receive high-dose chemotherapy followed by autologous stem cell transplantation. Tumor tissue samples must be available for central review, preferably collected within the last 2 months. Patients must have the mental capacity to provide informed consent and be able to follow study procedures.

Main exclusion criteria: Patients eligible for high-dose chemotherapy and autologous stem cell transplantation cannot participate. Those without relapsed or refractory disease, not in the specified age range, or unable to understand study requirements are also excluded.

Trial focus: The study compares whether MB-CART2019.1 can help patients live longer without disease progression compared to standard R-GemOx treatment (rituximab, gemcitabine, and oxaliplatin). Participants are randomly assigned to receive either the new CAR T-cell therapy or the standard combination treatment, with close monitoring to assess effectiveness and safety.

Investigational treatments: MB-CART2019.1 is a CAR T-cell therapy using modified immune cells to target cancer. The standard treatment arm uses rituximab (which targets CD20 proteins on cancer cells), gemcitabine (which interferes with cancer cell DNA), and oxaliplatin (which damages cancer cell DNA).

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 in Germany and Spain tests mosunetuzumab both as a single treatment and in combination with atezolizumab for patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.

Main inclusion criteria: Patients must agree to provide tumor samples (biopsy for NHL patients with multiple tumors, bone marrow biopsy and blood sample for CLL patients). They should have an ECOG performance status of 0 or 1, meaning they are fully active or have some symptoms but can still do light work. Life expectancy must be at least 12 weeks. Patients must have confirmed relapsed or refractory NHL or CLL expected to show CD20 protein, with no other available treatment expected to improve survival. For NHL patients, at least one measurable tumor larger than 1.5 cm (nodal) or 1.0 cm (extranodal) must be present on CT or MRI scan. Adequate liver, blood, and kidney function is required.

Main exclusion criteria: Patients with different cancer types than those being studied, those who have not experienced return or worsening of their NHL or CLL, those who have not received at least two previous treatments, patients not within the specified age range, those unable to safely tolerate study medications, and vulnerable populations not included in the study design are excluded.

Trial focus: The study evaluates the safety, tolerability, and effectiveness of mosunetuzumab alone and in combination with atezolizumab. It aims to determine the most effective dose and schedule for these treatments. Mosunetuzumab is administered either by subcutaneous injection (under the skin) or intravenous infusion, while atezolizumab is given through intravenous infusion. The trial includes regular monitoring, dose adjustments based on patient response, and follow-up visits to assess long-term effects.

Investigational treatments: Mosunetuzumab is a bispecific monoclonal antibody that engages the immune system to target and destroy cancer cells by binding to CD20 on B-cells and CD3 on T-cells. Atezolizumab helps the immune system attack cancer cells and is being tested in combination to potentially improve treatment outcomes.

Summary

The six ongoing clinical trials for recurrent B-cell lymphoma demonstrate a significant focus on innovative cell and gene therapies, particularly CAR T-cell treatments like MB-CART2019.1, which appears in multiple trials across different patient populations. The geographic distribution shows strong participation from Western and Central European countries, with Germany, France, Italy, and Spain hosting the most trials. Several studies specifically target patients who are not eligible for intensive treatments like high-dose chemotherapy and stem cell transplantation, addressing an important unmet need.

The trials span different age groups, including dedicated pediatric studies for children as young as 6 months, and adult studies for patients 18 years and older. Both antibody-based therapies (such as glofitamab, obinutuzumab, mosunetuzumab, and atezolizumab) and advanced CAR T-cell therapies are being investigated, reflecting the diverse approaches being taken to treat this challenging condition. Many trials include long-term follow-up components, with one study extending monitoring until 2040, emphasizing the importance of understanding the lasting safety and effectiveness of these novel treatments.

Ongoing Clinical Trials on B-cell lymphoma recurrent

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands

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

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Croatia Hungary

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