Study on the Safety and Effectiveness of AZD5492 Alone or with Other Treatments for Adults with Relapsed or Refractory B-Cell Blood Cancers

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What is this study about?

This clinical trial is focused on studying certain types of blood cancers known as B-cell malignancies. These include conditions like large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. The trial is testing a new treatment called AZD5492, which is a special type of medicine known as a T cell-engaging antibody. This medicine is designed to target a specific protein called CD20 found on the surface of cancer cells.

The purpose of the study is to find out if AZD5492 is safe and how well it works when used alone or with other cancer treatments. Participants in the study will receive AZD5492 as an injection under the skin. The study will take place over a period of time, during which participants will be closely monitored for any side effects and to see how their cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, doctors will check for any changes in the participants’ health, including any side effects or improvements in their condition. The study aims to gather important information about the safety and potential benefits of AZD5492 for people with these types of blood cancers. This information will help determine if AZD5492 could be a useful treatment option in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and performing necessary tests to ensure you meet the criteria for participation.

3 treatment phase

During the treatment phase, you will receive the study medication, AZD5492, which is a solution for injection administered under the skin (subcutaneous).

The dosage and frequency of administration will be determined by the study team based on your specific condition and response to the treatment.

You will be monitored closely for any side effects or reactions to the medication.

4 regular monitoring

Throughout the trial, regular monitoring will be conducted to assess your health and the effectiveness of the treatment. This includes physical exams, blood tests, and other necessary evaluations.

You will be asked to report any side effects or changes in your condition to the study team.

5 follow-up visits

After completing the treatment phase, follow-up visits will be scheduled to continue monitoring your health and gather additional data on the long-term effects of the treatment.

These visits are important to ensure your well-being and to collect information that may contribute to the study’s findings.

6 end of participation

At the end of your participation in the trial, a final assessment will be conducted. This includes a comprehensive review of your health status and any changes observed during the study.

You will receive information about any further steps or recommendations for your ongoing care.

Who Can Join the Study?

Must be 18 years of age or older.
Must have a type of cancer called CD20+ mature B-cell neoplasm. This includes specific types such as:
- Large B-cell lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
Must have a disease that has come back, is getting worse, or is not responding to treatment after trying at least two different treatments before.
Must have an ECOG performance status of less than 2. This is a scale used to assess how the disease affects daily living abilities, where lower numbers mean better ability to carry out daily activities.

Who Cannot Join the Study?

Patients who have a different type of cancer than B-Cell Malignancies cannot participate.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a serious uncontrolled medical condition, such as heart disease, cannot participate.
Patients who have had another cancer treatment within the last 4 weeks cannot participate.
Patients who have an active infection that requires treatment cannot participate.
Patients who have a known allergy to the study drug or similar drugs cannot participate.
Patients who have a history of drug or alcohol abuse within the last 6 months cannot participate.
Patients who are unable to comply with 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
Institut Gustave Roussy	Villejuif	France
Universitaetsmedizin Goettingen	Goettingen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Iebtblbw Czxfos Deeagiyhtdlgxgpsf	L'hospitalet De Llobregat	Spain
Arvutdd Uyduy Sztdifomi Leyzsv Dc Bwuurhn	Bologna	Italy
Uzwowagpoxpwryofzyhqo Wzdwfprux Aqg	Wuerzburg	Germany
Hibeenla Vexw dgpfmgtm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	29.08.2024
France	Recruiting	29.08.2024
Germany	Recruiting	29.08.2024
Italy	Recruiting	29.08.2024
Spain	Recruiting	29.08.2024

Trial locations

Investigated drugs:

Azd5492

AZD5492 is a special type of medicine called a T cell-engaging antibody. It is designed to help the body’s immune system target and fight cancer cells. In this study, AZD5492 is being tested to see how safe it is and how well it works for people with certain types of blood cancers that have come back or have not responded to other treatments. The medicine works by attaching to a specific protein found on the surface of cancer cells, which helps the immune system recognize and destroy these cells.

Investigated diseases:

B-cell lymphoma

B-Cell Malignancies – B-cell malignancies are a group of cancers that affect B lymphocytes, which are a type of white blood cell responsible for producing antibodies. These malignancies can include various types of lymphomas and leukemias, such as chronic lymphocytic leukemia and non-Hodgkin lymphoma. The disease often begins with the abnormal growth of B-cells in the lymph nodes, bone marrow, or blood. As the disease progresses, it can lead to the enlargement of lymph nodes, spleen, or liver, and may cause symptoms like fatigue, fever, and weight loss. Over time, the abnormal B-cells can interfere with the normal production of blood cells, leading to anemia or increased risk of infections. The progression and specific symptoms can vary depending on the type of B-cell malignancy.

Trial ID:

2024-511099-34-00

Protocol code:

TITANium

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety and Effectiveness of AZD5492 Alone or with Other Treatments for Adults with Relapsed or Refractory B-Cell Blood Cancers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?