Not recruitingRare disease

Study on the Safety and Effectiveness of BCMACP03 for Patients with Relapsed or Refractory Multiple Myeloma

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What is this trial about?

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

This clinical trial is focused on studying a type of blood cancer called Multiple Myeloma, specifically in patients whose disease has returned or is not responding to treatment, known as relapsed/refractory Multiple Myeloma. The treatment being tested is a new form of therapy called BCMACP03, which involves using specially modified cells to target and fight the cancer. These cells are known as anti-BCMA CAR T cells, and they are created using a process that involves a virus called Lentivirus to modify the patient's own immune cells, known as T cells, to better recognize and attack the cancer cells.

The purpose of this study is to evaluate how safe and effective this new treatment is for patients with relapsed/refractory Multiple Myeloma. The study is divided into two phases. In the first phase, the focus is on determining the safety of the treatment and finding the right dose. In the second phase, the study will look at how well the treatment works in reducing the cancer. Participants will receive the treatment through an intravenous infusion, which means it will be given directly into the bloodstream through a vein.

Throughout the study, researchers will monitor participants for any side effects and measure how the cancer responds to the treatment. The study aims to provide valuable information on the potential benefits and risks of using BCMACP03 for treating relapsed/refractory Multiple Myeloma, with the hope of offering a new option for patients who have limited treatment choices. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the long-term effects and effectiveness of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your agreement to participate.
You must agree to use highly effective methods of contraception from the time of signing the informed consent form until at least 12 months after the infusion of the study medication, GLPG5301.
Step 2
Screening
During the screening phase, your eligibility for the study will be assessed. This includes confirming your diagnosis of relapsed/refractory multiple myeloma and ensuring you meet specific health criteria.
A negative serum pregnancy test is required for women of childbearing potential before proceeding to the next steps.
Step 3
Treatment preparation
If eligible, you will undergo preparation for the treatment. This may involve additional health assessments to ensure your readiness for the infusion of BCMACP03.
You will receive detailed instructions on what to expect during the treatment phase.
Step 4
Treatment administration
The study medication, BCMACP03, will be administered to you through an intravenous infusion. This means the medication will be given directly into your bloodstream through a vein.
The infusion process will be monitored closely by healthcare professionals to ensure your safety.
Step 5
Post-treatment monitoring
After the infusion, you will be monitored for any side effects or adverse reactions. This monitoring will continue for a specified period to ensure your well-being.
Regular follow-up visits will be scheduled to assess the effectiveness of the treatment and to monitor your health status.
Step 6
Long-term follow-up
You will be part of a long-term follow-up phase, which may last up to two years. During this time, your response to the treatment will be evaluated.
The study team will collect information on your health, any side effects, and the overall impact of the treatment on your condition.

Who can join the trial?

10 criteria

Signed informed consent form.
Women who can have children and all men must agree to use very effective birth control methods and not donate eggs or sperm from the time they sign the consent form until at least 12 months after receiving the study treatment.
Must be at least 18 years old at the time of signing the consent form.
Must have a diagnosis of Multiple Myeloma according to specific medical guidelines.
Must have a disease that has returned or not responded to at least two previous treatments, including specific types of drugs and therapies. The disease must have shown signs of worsening within 60 days of the last treatment.
Must have measurable disease at screening, which means certain levels of specific proteins in the blood or urine are present.
Must have a performance status of 0 or 1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, lymphocytes, and T cells in the blood.
Must have adequate kidney, liver, and lung function, which includes specific levels of creatinine clearance, liver enzymes, bilirubin, and oxygen saturation in the blood.
Women who can have children must have a negative pregnancy test at screening and before the first dose of specific chemotherapy.

Who cannot join the trial?

3 criteria

Patients who do not have relapsed/refractory Multiple Myeloma cannot participate. This means the study is only for those whose multiple myeloma has returned or did not respond to previous treatments.
Patients who are not within the specified age range cannot participate. The study is for adults only.
Patients who are part of a vulnerable population cannot participate. This includes groups who may need special protection in research settings.

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Verified sites

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Responsive
Academisch Ziekenhuis Leiden
Leiden, The Netherlands
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

GLPG5301
is a medication being tested in this clinical trial to see if it is safe and effective for people with a type of blood cancer called Multiple Myeloma that has come back or has not responded to treatment. The trial is in two parts. In the first part, researchers are checking if GLPG5301 is safe to use and finding out the best dose to give to patients. In the second part, they are looking at how well the medication works in treating the cancer by measuring how much the cancer shrinks or disappears.
BCMACP03
is a type of therapy that uses specially modified cells to fight cancer. In this trial, the therapy involves taking a patient's own immune cells and changing them in a lab so they can better recognize and attack cancer cells. These modified cells are then put back into the patient's body. This therapy is being tested to see if it is a feasible and safe treatment option for people with Multiple Myeloma that has returned or is not responding to other treatments.

Bcmacp03

What is already known about the treatment

GLPG5301 – This medication is administered as a form of cell therapy, specifically using anti-BCMA CAR T cells, which are a type of genetically modified immune cells. It is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory Multiple Myeloma, a type of blood cancer. The main therapeutic use of GLPG5301 is to target and destroy cancer cells in patients who have not responded to other treatments. At the molecular level, it works by recognizing and binding to a specific protein called BCMA on the surface of cancer cells, leading to their destruction. This medication falls under the pharmacological classification of immunotherapy, which uses the body's immune system to fight cancer.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, cancerous plasma cells multiply excessively, leading to an overproduction of abnormal proteins and crowding out healthy blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the disruption of normal bone marrow function. Patients may also experience kidney problems and increased susceptibility to infections. The disease often goes through periods of remission and relapse, where symptoms may improve and then worsen again. Over time, the accumulation of abnormal proteins can lead to organ damage, particularly affecting the kidneys and bones.