Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Not recruiting
Study of BI-1206, Rituximab, and Acalabrutinib for Patients with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a type of cancer called Indolent B-Cell Non-Hodgkin Lymphoma, which is a slow-growing cancer that affects a type of white blood cell. The study is testing a new treatment involving a medication called BI-1206, which is a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific targets in the body, in this case, a part of the immune system. The trial will also use another medication called Rituximab, which is already used to treat this type of cancer, and may include Acalabrutinib, a drug that helps to block certain signals that cancer cells use to grow.
The purpose of the study is to assess the safety and how well patients tolerate the combination of these medications. The study will be conducted in two phases. In the first phase, the focus will be on finding the safest dose of BI-1206 when given with Rituximab. In the second phase, the study will explore the best dose of BI-1206 when used with both Rituximab and Acalabrutinib. Participants will receive the medications either through an injection under the skin or through an infusion into a vein.
Throughout the study, participants will be closely monitored for any side effects and how their cancer responds to the treatment. The study aims to find out if this new combination of medications can help patients whose cancer has returned or did not respond to previous treatments. The trial will also look at how the body processes the medications and how they affect the cancer cells. This research is important for developing new treatment options for patients with Indolent B-Cell Non-Hodgkin Lymphoma.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Must be at least 18 years old when starting the study treatment.
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
- Must have a CD20+ malignancy, which means a type of cancer that tests positive for a specific protein called CD20, confirmed by tests done on a recent biopsy after previous anti-CD20 treatment.
- Must have certain blood and chemical levels within specific ranges, including hemoglobin (at least 9.0 g/dL), absolute neutrophil count (ANC) (at least 1.0 x 109/L, or more than 0.5 x 109/L if due to lymphoma), and platelet count (at least 100 x 109/L). These tests must be done within one week before the first dose of BI-1206.
- Must provide written consent to participate in the study.
- Must be able to cooperate with the treatment and follow-up procedures.
- Must have B-cell Non-Hodgkin Lymphoma (NHL) confirmed by tissue examination, with specific types including follicular lymphoma (except grade 3B), mantle cell lymphoma, and marginal zone lymphoma.
- Must have measurable nodal disease, meaning at least one lymph node that is 1.5 cm or larger in one dimension, as seen on a CT or MRI scan.
- Must be willing to have a biopsy of a lymph node or other affected tissue, unless it is not possible. If a suitable sample from a previous biopsy within the last 8 weeks is available, a new biopsy is not needed.
- Must have disease that has returned or not responded to standard treatment, or for which no standard treatment exists, or if the available standard treatment is not suitable or is declined by the patient. Rituximab refractory disease is defined as not achieving complete or partial response during treatment with rituximab, or disease progression within a year after completing rituximab treatment, or during or within 6 months after rituximab maintenance therapy.
- Must have received at least one previous treatment that included rituximab.
- Must have a life expectancy of at least 12 weeks from the first infusion of BI-1206.
Who cannot join the trial?
10 criteria
- Patients who have a different type of cancer than the ones being studied cannot participate.
- Patients who have had a severe allergic reaction to any of the study drugs in the past cannot participate.
- Patients who are currently pregnant or breastfeeding cannot participate.
- Patients who have an active infection that requires treatment cannot participate.
- Patients who have a serious heart condition that is not well controlled cannot participate.
- Patients who have a history of another cancer that is not in remission cannot participate.
- Patients who are taking certain medications that might interfere with the study drugs cannot participate.
- Patients who have a condition that affects their immune system, making it weaker, cannot participate.
- Patients who have had a major surgery within the last 4 weeks cannot participate.
- Patients who have a history of drug or alcohol abuse that could affect their ability to follow the study procedures cannot participate.
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Verified Verified Hospital General Universitario Gregorio Maranon
Madrid, SpainResponsive Hospital Universitario Hm Sanchinarro
Madrid, Spain
Trial locations
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Investigated drugs
BI-1206
is a monoclonal antibody designed to target a specific protein called CD32b, which is found on certain immune cells. In this trial, it is being tested to see if it can help treat a type of cancer called indolent B-cell non-Hodgkin lymphoma, which has either come back or not responded to previous treatment. BI-1206 is given either through an IV (intravenous) or as an injection under the skin (subcutaneous).
Rituximab
is a medication that is commonly used to treat certain types of cancer, including non-Hodgkin lymphoma. It works by targeting a protein on the surface of cancer cells, helping the immune system to destroy them. In this trial, rituximab is used in combination with BI-1206 to see if the two drugs together can be more effective in treating the lymphoma.
Acalabrutinib
is a medication that helps to block certain signals in cancer cells that they need to grow. It is used to treat some types of blood cancers. In this trial, acalabrutinib is combined with BI-1206 and rituximab to explore if this combination can improve treatment outcomes for patients with indolent B-cell non-Hodgkin lymphoma.
What is already known about the treatment
BI-1206
This medication is administered either intravenously or subcutaneously and is currently being studied in clinical trials for its use in treating indolent B-cell non-Hodgkin lymphoma, particularly in cases that have relapsed or are refractory to rituximab. BI-1206 is a monoclonal antibody targeting CD32b, a receptor involved in regulating immune responses. By blocking this receptor, BI-1206 may enhance the effectiveness of other treatments like rituximab. It is classified as an immunotherapy agent, specifically a monoclonal antibody.
Rituximab
This medication is administered intravenously and is well-established in medical practice for treating various types of B-cell non-Hodgkin lymphoma. Rituximab works by targeting the CD20 protein on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody and is widely used in combination with other therapies to improve treatment outcomes.
Acalabrutinib
This medication is taken orally and is used in the treatment of certain types of B-cell non-Hodgkin lymphoma. Acalabrutinib works by inhibiting Bruton's tyrosine kinase (BTK), a protein that plays a crucial role in the survival and proliferation of cancerous B-cells. It is classified as a kinase inhibitor and is often used in combination with other treatments to enhance therapeutic effects.
Investigated diseases
Indolent B-Cell Non-Hodgkin Lymphoma – This is a type of cancer that affects the lymphatic system, specifically targeting B-cells, which are a type of white blood cell. It is characterized by slow growth and progression, often presenting with painless swelling of lymph nodes. Over time, it can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include fatigue, night sweats, and unexplained weight loss. The disease is considered indolent because it progresses more slowly compared to other forms of lymphoma. Despite its slow progression, it requires monitoring and management to prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512972-36-00Protocol code17-BI-1206-02Estimated enrolment152 patientsSponsorBioInvent International AB
sourced from the EU Clinical Trials Register and site verification
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