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A study of Cesnicabtagene autoleucel compared to a drug combination for patients with relapsed or refractory multiple myeloma

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What is this study about?

This study focuses on individuals with multiple myeloma, a type of blood cancer, specifically those with relapsed/refractory multiple myeloma. This means the cancer has returned after previous treatments or has stopped responding to them. The purpose of the study is to compare a new treatment called Cesnicabtagene autoleucel against the current standard medical care to see which is more effective at preventing the disease from worsening.

The new treatment, Cesnicabtagene autoleucel, is a type of CAR T-cell therapy. This involves using T lymphocytes, which are a type of white blood cell that helps the body fight infection, that have been genetically modified in a lab to specifically target BCMA, a protein found on the surface of cancer cells. Participants in the study will receive either this modified cell therapy or a standard regimen consisting of other medications such as carfilzomib, daratumumab, cyclophosphamide monohydrate, dexamethasone, bortezomib, elotuzumab, or pomalidomide.

During the study, researchers will monitor how long patients live without their disease getting worse, known as progression free survival. Other aspects being observed include the overall response to the medicine, the presence of MRD-negativity, which means that very small amounts of cancer cells cannot be detected in the body, and the general safety and side effects of the treatments. The study also looks at how long the treatment remains effective and the overall quality of life for those involved.

Who Can Join the Study?

  • A person who has a documented history of multiple myeloma, which is a type of blood cancer.
  • Patients must have already received between 2 and 4 different types of antimyeloma therapy, which are treatments used to fight this specific cancer.
  • These previous treatments must have included an IMiD, a PI, and an anti-CD38 mAb, which are specific classes of cancer-fighting drugs.
  • The cancer must be refractory, meaning it has stopped responding to the most recent treatment received.
  • The cancer must be measurable, meaning it can be clearly seen and tracked through medical tests.
  • Patients must be able to receive at least one of the standard current treatments, known as SoC or standard of care.
  • Participants must be 18 years of age or older.
  • Patients must be able to provide informed consent, which means they fully understand the study and agree to participate.
  • Patients must have an ECOG/WHO performance status of 0 to 2, which is a scale used by doctors to measure how well a person can perform daily activities and their overall physical health.
  • Patients must have adequate function of their blood cells (hematological), kidneys (renal), liver (hepatic), lungs (pulmonary), and heart (cardiac).

Who Cannot Join the Study?

  • You have previously received treatments that target BCMA (a specific protein on cancer cells), T-cell engager therapy (a treatment that helps the immune system find cancer), CAR T-cell therapy, or other types of genetically modified T-cell therapy (treatments where immune cells are changed in a lab to fight cancer).
  • You have or have had central nervous system (CNS) or meningeal involvement, which means the cancer is present in or affecting the brain or the protective layers covering the brain and spinal cord.
  • The cancer is located in the atria or ventricles of your heart (the upper or lower chambers of the heart).
  • You have a history of or are currently experiencing plasma cell leukemia (a type of blood cancer), Waldenstrom’s macroglobulinemia (a rare type of blood cancer), polyneuropathy (damage to the nerves that can cause numbness or weakness), organomegaly (an enlargement of internal organs), endocrinopathy (a disease affecting the hormone-producing glands), monoclonal protein (an abnormal protein found in the blood), POEMS syndrome (a rare condition involving various organ and nerve issues), or amyloidosis (a condition where abnormal proteins build up in organs).
  • You have an active or suspected fungal, bacterial, or viral infection that is not under control or requires intravenous (IV) antimicrobials (medicines given directly into a vein to fight infection).
  • You are a female who is pregnant or breastfeeding.
  • You are unwilling to use highly effective birth control (methods used to prevent pregnancy).
  • Your expected remaining life is less than 12 weeks.
  • You are currently participating in a different clinical trial (a research study involving human participants).

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Uziibffdmtai Mcwbetz Cbalewv Grkkfhmtn Groningen The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.08.2026

Trial locations

Investigated drugs:

Cesnicabtagene autoleucel is an experimental therapy that uses a patient’s own modified immune cells. These cells are taken from the patient, genetically changed in a lab to recognize and attack specific proteins on cancer cells, and then infused back into the patient to fight the disease.

Carfilzomib is a medication given through an IV infusion that helps to stop the growth of cancer cells by interfering with the proteins that cancer cells need to survive.

Daratumumab is a medication given as an injection under the skin that targets specific proteins on the surface of certain cancer cells to help the immune system find and destroy them.

Cyclophosphamide is a medication taken by mouth that works as a chemotherapy to prevent cancer cells from growing and multiplying.

Dexamethasone is a type of steroid medication taken by mouth that is used to help reduce inflammation and manage certain side effects.

Bortezomib is a medication given as an injection under the skin that works to block the processes that allow cancer cells to live and multiply.

Elotuzumab is a medication given through an IV infusion that helps the immune system recognize and attack cancer cells by targeting specific proteins on their surface.

Pomalidomide is a medication taken by mouth that helps to treat cancer by influencing the immune system and interfering with the growth of cancer cells.

Investigated diseases:

Relapsed/refractory multiple myeloma – This is a type of cancer that develops in the plasma cells, which are a type of white blood cell. The disease occurs when these cells grow out of control in the bone marrow. In the relapsed or refractory stage, the cancer has returned after a period of improvement or has stopped responding to previous treatments. As the condition progresses, the abnormal plasma cells can accumulate and interfere with normal blood cell production. This accumulation often leads to various changes in the body’s systems.

Trial ID:
2025-524876-43-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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