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A study of DS-3790A, rituximab, and epcoritamab in patients with blood cancers

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Hematological Malignancies, which are cancers that affect the blood and the organs that produce blood, such as the bone marrow. The research aims to evaluate the safety and early effectiveness of a new drug called DS-3790A, which is an antibody-drug conjugate, a type of medication designed to deliver a potent drug directly to specific cancer cells. This study will also involve the use of epcoritamab and rituximab as comparison treatments.

The trial will observe how the body responds to DS-3790A when it is used alone or in combination with other medicines. The course of the study involves administering these medications through an infusion, which is a method of delivering fluids or medicine directly into a vein. Researchers will monitor for any side effects or changes in the disease to understand how well the treatment works.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>participation in the study</b>
The study involves receiving either the test medication, ds-3790a, which is provided as a solution for infusion (a liquid medicine delivered directly into a vein), or comparator medications, which include epcoritamab or rituximab.
Step 2
<b>safety and efficacy monitoring</b>
The primary focus is to monitor safety and how well the medication works. this includes tracking adverse events, which are any unwanted or harmful medical occurrences, and dose-limiting toxicities, which are side effects serious enough to prevent further increases in the medication dose.
The effectiveness of the treatment is measured by looking for a complete response, which means the signs and symptoms of the hematological malignancy (a type of cancer affecting the blood or bone marrow) have disappeared.

Who can join the trial?

11 criteria

You must be at least 18 years old when you sign the agreement to join the study.
You must sign and date the Informed Consent Form, which is a document that explains all the details of the study before any tests begin.
You must have a confirmed diagnosis of hematologic malignancies, which are types of cancer that affect the blood, bone marrow, or lymph nodes.
You must agree to provide tumor samples, which means small pieces of tissue from the cancer area for testing.
You must have an ECOG Performance Status of 0, 1, or 2. This is a scale used by doctors to measure how well you can perform daily activities and how much your illness affects your physical strength.
Your organ and bone marrow function must be healthy, as measured by blood tests taken within the last 14 days. Bone marrow is the spongy tissue inside bones that produces blood cells.
Your left ventricular ejection fraction must be 50% or higher. This is a measurement of how much blood your heart pumps out with each beat to show how well the heart is working. This will be checked using a heart scan.
You must have a life expectancy of at least 3 months.
You must be willing and able to follow the study schedule, including visits, taking the medicine, and undergoing laboratory tests.
Women of childbearing potential (women who are able to become pregnant) can join if they meet all specific study rules.
Men capable of producing sperm can join if they agree to all specific study rules.

Who cannot join the trial?

12 criteria

You have previously had an allogeneic stem cell transplant, which is a procedure where healthy blood-forming cells are taken from a donor and given to a patient.
You have ongoing toxicities, meaning harmful side effects, from previous cancer treatments that have not returned to a low or normal level.
You have an active or uncontrolled infection caused by bacteria, fungi (like yeast or mold), or viruses throughout your body.
You have an active or uncontrolled infection of Hepatitis B, Hepatitis C, or HIV (human immunodeficiency virus).
You have previously received a solid organ transplant, such as a kidney, liver, or heart transplant.
You have not waited long enough for previous medications to leave your system, known as an inadequate washout period.
You have brain or leptomeningeal disease, which means cancer has spread to the brain or the protective layers surrounding the brain and spinal cord, unless it has been treated and shown to be stable on imaging for at least 4 weeks.
You have cardiovascular disease, which refers to conditions affecting the heart or blood vessels, that is not under control.
You have experienced a cerebrovascular accident (commonly known as a stroke), a transient ischemic attack (a temporary blockage of blood flow to the brain), or other thromboembolic events (blood clots that travel in the bloodstream) within the last 6 months.
You have a history of interstitial lung disease or pneumonitis (inflammation of lung tissue) that required corticosteroids (strong anti-inflammatory medicines), or you currently have these conditions, or they cannot be ruled out by medical scans.
You have severe pulmonary compromise, which means your lung function is significantly impaired due to other current illnesses.
You have been diagnosed with a different type of malignancy (cancer) within the past 3 years.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Unita Sanitaria Locale Di Bologna
Verified
Bologna, Italy
Centre Hospitalier Universitaire De Lille
Verified
Lille, France
Institut Gustave Roussy
Verified
Villejuif, France

Trial locations

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Investigated drugs

Epcoritamab
is a medication used to help the body's immune system find and attack certain types of cancer cells.
Rituximab
is a type of medicine that targets and helps destroy specific proteins found on the surface of certain cancer cells.
DS-3790A
is an experimental therapy being tested in this study to see if it can effectively target and kill cancer cells in people with blood-related cancers.

What is already known about the treatment

Epcoritamab
This medication is an immune-based therapy used to treat certain types of blood cancers. It is administered through injections or infusions to help the body's immune system find and destroy cancer cells. It works by acting as a bridge, physically linking immune cells to cancer cells so the immune system can attack them more effectively. This drug is classified as a bispecific antibody.
Rituximab
This is an established medication used to treat various blood cancers and autoimmune diseases. It is typically given through an intravenous infusion into a vein. It works by attaching to a specific protein called CD20 found on the surface of certain immune cells, which signals the body to destroy those specific cells. This drug is classified as a monoclonal antibody.
DS-3790A
This is an experimental drug currently being studied in clinical trials for the treatment of blood cancers. It is provided as a solution for infusion, meaning it is delivered directly into a vein. This medication belongs to a class called antibody-drug conjugates, which work by using an antibody to deliver a powerful dose of medicine directly into the cancer cells while sparing most healthy cells.

Investigated diseases

Hematological malignancies - These are a group of cancers that affect the blood and the organs that produce it, such as the bone marrow. They occur when abnormal cells grow uncontrollably, often originating from white blood cells, red blood cells, or platelets. As these diseased cells multiply, they crowd out healthy blood cells in the body. This process can disrupt the normal functions of the immune system and blood clotting. The condition can progress by affecting different parts of the blood-forming system over time.