Study on the Safety and Effectiveness of AZD0486 Alone or with Other Drugs for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, or Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying certain blood cancers, specifically Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, and Large B-Cell Lymphoma. The trial will evaluate the safety and effectiveness of a new treatment called AZD0486, which is a type of medication known as a monoclonal antibody. This treatment can be used alone or in combination with other cancer-fighting drugs such as Doxorubicin, Rituximab, Prednisolone, Cyclophosphamide, Vinorelbine, and Acalabrutinib.

The purpose of the study is to determine how safe and tolerable AZD0486 is when given to patients with these types of blood cancers. The study will also find the best dose to use in future research. Participants will receive the treatment either through an infusion into a vein or an injection under the skin. The study will be conducted in several phases, starting with a smaller group of participants to assess safety, and then expanding to include more participants to further evaluate the treatment’s effectiveness.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The trial aims to provide valuable information on how well AZD0486 works in treating these blood cancers and to ensure that it is safe for patients. The study is expected to continue until 2026, with recruitment starting in 2025.

1 initial treatment phase

The initial treatment phase involves the administration of AZD0486, a human igg4 kappa monoclonal antibody against cd3 and cd19. This medication is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein.

During this phase, the patient may also receive rituximab and doxorubicin hydrochloride, both administered intravenously. These medications are part of the treatment regimen for certain blood cancers.

2 combination therapy phase

In the combination therapy phase, AZD0486 may be used alongside other anticancer agents. These include acalabrutinib, which is taken orally as a 100 mg film-coated tablet, and cyclophosphamide, administered intravenously.

Additional medications such as vinorelbine and betamethasone sodium phosphate may also be included in the treatment plan, depending on the specific requirements of the patient’s condition.

3 maintenance phase

The maintenance phase focuses on sustaining the treatment’s effectiveness. Prednisolone is taken orally to help manage inflammation and other symptoms associated with the condition.

Regular monitoring of the patient’s response to the treatment is conducted to ensure the best possible outcomes.

4 follow-up and monitoring

Throughout the trial, the patient’s health is closely monitored. This includes regular assessments of vital signs, laboratory tests, and evaluations of any side effects experienced.

The trial aims to assess the safety and tolerability of the treatment, as well as to determine the recommended dose for future studies.

Who Can Join the Study?

Must be over 18 years old.
For Sub-study 2: Must have a diagnosis of Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO).
For Sub-study 2: Must be in Stage II, III, or IV according to the Ann Arbor classification, which is a way to describe the extent of lymphoma.
For Sub-study 2: Must have at least one measurable site of disease as per the Lugano classification, which is a method to assess lymphoma.
For Sub-study 2: Must have an Absolute Lymphocyte Count (ALC) of less than 10,000. Lymphocytes are a type of white blood cell.
For Sub-study 2, Cohort 2A: Must have experienced a relapse after two or more lines of therapy, including treatment with a BTK inhibitor (BTKi), which is a type of medication.
For Sub-study 2, Cohort 2B: Must have experienced a relapse or progression after one or more lines of therapy, not including a BTKi.
For Sub-study 3: Must have Large B-cell lymphoma according to WHO 2022 or have relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) after at least one prior line of therapy.
For Sub-study 3: Must have an International Prognostic Index (IPI) score of 2-5, which helps predict the outcome of lymphoma.
For Sub-study 3: Must have at least one measurable site of disease as per the Lugano classification.
For Sub-study 3: Must have a Left Ventricular Ejection Fraction (LVEF) greater than 50%. LVEF is a measure of how well the heart pumps blood.
For all sub-studies: Must have an ECOG performance status of 0 to 2, which is a scale to assess how a disease affects daily living abilities.
For Sub-study 3: Must use contraception for at least 12 months after the last dose of R-CHOP (a chemotherapy regimen) or 6 months after the last dose of AZD0486.
For all sub-studies: Must use contraception during treatment and for at least 6 months after the final dose.
For all sub-studies: Must have confirmed CD19 expression if previously treated with anti-CD19 therapy. CD19 is a protein found on the surface of certain cells.
For Sub-study 1: Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and meet the iwCLL criteria for treatment, which are guidelines for treating CLL.
For Sub-study 1: For SLL, must have at least one measurable site of disease as per the Lugano classification.
For Sub-study 1: Must have an absolute lymphocyte count of less than 10,000.
For Sub-study 1, Cohort 1A: Must have had at least two prior lines of therapy, including treatment with a BTKi and a BCL2 inhibitor (BCL2i), which are types of medications.
For Sub-study 1, Cohort 1B: Must have had at least one prior line of therapy and be sensitive to or not previously treated with a BTKi.

Who Cannot Join the Study?

Patients with medical conditions other than Large B-Cell Lymphoma, Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma, or Mantle Cell Lymphoma cannot participate.
Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
Participants who are part of a vulnerable population, which means groups that may need special protection, are not eligible.
Both male and female participants are considered, so gender is not an exclusion factor.

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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Institute Of Hematology And Blood Transfusion	Prague	Czechia
Odense University Hospital	Odense	Denmark
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Servei De Salut De Les Illes Balears	Palma	Spain
University Hospital Ostrava	Ostrava	Czechia
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Adyprpwrnk Poczbqeh Hfwajvul Dn Pwrst	Paris	France
Kjcplxzv dnq Upziujczsytv Mohivocb Afr	Munich	Germany
Uaqqlwssepdgdjhyvuoqw Wmvtohshv Acc	Wuerzburg	Germany
Uiorfohgdf Hqbednuo Chejsxi	Cologne	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	28.03.2025
Denmark	Recruiting	28.03.2025
France	Recruiting	28.03.2025
Germany	Recruiting	28.03.2025
Spain	Recruiting	28.03.2025

Trial locations

Investigated drugs:

AZD0486 is an investigational medication being studied for its potential to treat certain types of blood cancers known as mature B-cell malignancies. This includes conditions like Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, and Large B-Cell Lymphoma. The medication is being tested both on its own and in combination with other cancer treatments to evaluate its safety and effectiveness. The study aims to find the best dose for future research.

Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, spleen, liver, or other organs. The disease can spread to other parts of the body, including the bone marrow and central nervous system. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

Chronic Lymphocytic Leukemia – This is a slow-growing cancer of the blood and bone marrow that primarily affects older adults. It involves the production of too many abnormal lymphocytes, a type of white blood cell. Over time, these abnormal cells can crowd out healthy blood cells, leading to symptoms such as fatigue, infections, and swollen lymph nodes. The disease often progresses slowly, and some individuals may not experience symptoms for years.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that is closely related to chronic lymphocytic leukemia. It primarily affects the lymph nodes and is characterized by the accumulation of small, mature lymphocytes. The disease progresses slowly and may present with symptoms such as painless swelling of lymph nodes, fatigue, and night sweats. It is considered the same disease as chronic lymphocytic leukemia but with a different primary location.

Mantle Cell Lymphoma – This is a rare type of non-Hodgkin lymphoma that arises from B cells located in the “mantle zone” of the lymph node. It is characterized by the overproduction of abnormal B cells, which can spread to other parts of the body, including the bone marrow and gastrointestinal tract. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease is typically aggressive and can progress rapidly.

Trial ID:

2024-515034-33-00

Protocol code:

D7407C00001

NCT ID:

NCT06564038

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of AZD0486 Alone or with Other Drugs for Adults with Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, or Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?