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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Hospices Civils de Lyon -Hôpital Lyon Sud Pierre Benite France
Aylahza Upraa Sjwakpoeh Lmbyrz Df Bnopbpk Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.04.2026
Italy Italy
Not yet recruiting
01.04.2026

Trial locations

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.

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.

Trial ID:
2025-522595-87-00
Protocol code:
DS3790-076
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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