Not yet recruitingRare disease

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

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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
After joining the study, a group is assigned to receive either the test treatment or the standard treatment.
Step 2
Test treatment phase
The test treatment involves an infusion of cesnicabtagene autoleucel. this is a type of therapy where genetically modified cells are delivered through a vein.
Step 3
Standard treatment phase
The standard treatment consists of a combination of different medications. these may include carfilzomib, which is given as an intravenous infusion at a dose of 70 mg/m2, daratumumab, given as a subcutaneous injection at a dose of 1800 mg, cyclophosphamide, which is an oral tablet at a dose of 50 mg, and dexamethasone, which is an oral tablet at a dose of 40 mg.
Step 4
Alternative standard treatment options
Depending on the assigned regimen, other medications may be used. these include bortezomib, given as a subcutaneous injection at a dose of 1.3 mg/m2; elotuzumab, given as an intravenous infusion at a dose of 20 mg/kg; or pomalidomide, given as an oral capsule at a dose of 4 mg.

Who can join the trial?

10 criteria

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 trial?

9 criteria

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).

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Verified sites

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Universitair Medisch Centrum Groningen
Verified
Groningen, The Netherlands

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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.

What is already known about the treatment

Carfilzomib
This medication is a proteasome inhibitor used to treat certain types of blood cancer, specifically relapsed or refractory multiple myeloma. It is administered as a solution through an intravenous infusion into a vein. On a molecular level, it works by blocking a specific protein complex in cancer cells that is responsible for breaking down old or damaged proteins, which eventually leads to the death of the cancer cell.
Daratumumab
This is a targeted therapy used in the treatment of multiple myeloma and is administered via a subcutaneous injection under the skin. It is classified as a monoclonal antibody that works by attaching to a specific protein called CD38 on the surface of myeloma cells. This attachment signals the body's own immune system to recognize and destroy the cancer cells.
Cyclophosphamide monohydrate
This is a chemotherapy medication used to treat various types of cancer, including multiple myeloma, and is taken orally in tablet form. It belongs to a group of drugs called alkylating agents that work by damaging the DNA within cancer cells. This damage prevents the cancer cells from multiplying and ultimately causes them to die.
Cesnicabtagene autoleucel
This is an advanced gene therapy involving genetically modified immune cells used to treat relapsed or refractory multiple myeloma. It is administered through an intravenous infusion of a liquid dispersion containing the modified cells. These engineered cells are designed to find and attach to a specific marker called BCMA on the surface of cancer cells, allowing the immune system to attack the tumor directly.
Dexamethasone
This is a corticosteroid used to help manage inflammation and reduce side effects during cancer treatment. It is taken orally in tablet form. It works by calming the body's immune response and reducing swelling and irritation at the molecular level.
Bortezomib
This medication is a proteasome inhibitor used for the treatment of multiple myeloma and is given as a subcutaneous injection under the skin. It functions by stopping the cancer cells from recycling their waste products, which causes a buildup of toxic materials that kills the cell.

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.