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 study about?

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.

1 initial treatment phase

The trial begins with the administration of BI-1206, a monoclonal antibody, which is given either as a solution for injection under the skin or as a solution for infusion into a vein. This is combined with rituximab, another medication used to treat certain types of lymphoma.

The purpose of this phase is to assess the safety and tolerability of BI-1206 when used with rituximab. The dosage and method of administration are determined based on individual patient needs and responses.

2 combination treatment phase

In this phase, BI-1206 is administered in combination with both rituximab and acalabrutinib, which is taken orally as a film-coated tablet. Acalabrutinib is used to help manage certain types of lymphoma.

The goal is to find the recommended dose of BI-1206 when used with both rituximab and acalabrutinib, ensuring the treatment is effective and well-tolerated.

3 monitoring and assessment

Throughout the trial, regular monitoring is conducted to document any adverse effects and to assess the overall response to the treatment. This includes measuring the depletion of B cells, which are a type of white blood cell involved in the immune response.

The trial also evaluates the expression levels of certain proteins, such as CD32b, which may provide insights into the effectiveness of the treatment.

4 conclusion of trial participation

The trial is expected to continue until May 2031, with individual participation lasting as long as necessary to achieve the trial’s objectives. The duration of participation may vary based on individual responses and the specific phase of the trial.

Upon completion, participants will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Clinico Universitario Virgen De La Arrixaca	El Palmar	Spain
Hguuubjk Db Lw Smown Cvji I Svhf Pqi	Barcelona	Spain
Itckwfba Cslahr Dyjvxlajeegcnsmui	L'hospitalet De Llobregat	Spain
Htviztqx Vwuo djgfzxed	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	21.05.2018
Spain	Not recruiting	21.05.2018

Trial locations

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.

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 ID:

2024-512972-36-00

Protocol code:

17-BI-1206-02

NCT ID:

NCT03571568

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of BI-1206, Rituximab, and Acalabrutinib for Patients with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma

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