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Study on the Safety and Effectiveness of ARI0002h and Drug Combination for Newly Diagnosed Primary Plasma Cell Leukemia Patients

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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 primary plasma cell leukemia. The study is testing a new treatment called ARI0002h, also known as Cesnicabtagene autoleucel. This treatment involves using a patient's own immune cells, which are genetically modified to better fight the cancer. These modified cells are called CAR-T cells, and they are designed to target a specific protein found on the cancer cells known as BCMA.

The purpose of the study is to evaluate the safety and effectiveness of this new treatment in patients who have been newly diagnosed with primary plasma cell leukemia. Participants in the study will receive the ARI0002h treatment through an infusion, which is a method of delivering medication directly into the bloodstream. The study will monitor how well the treatment works in reducing the cancer and will also look at any side effects that may occur. Some patients may receive additional medications such as Lenalidomide, Cyclophosphamide, Fludarabine, Paracetamol, or Tocilizumab to help manage symptoms or enhance the treatment's effectiveness.

The study will take place over several months, with regular check-ups to assess the response to the treatment and monitor for any side effects. The goal is to see if the treatment can help control the disease and improve the quality of life for patients with primary plasma cell leukemia. Participants will be closely monitored for any reactions to the treatment, including potential side effects like cytokine release syndrome and neurological symptoms. The study aims to provide valuable information on the potential benefits and risks of using ARI0002h for this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The initial treatment phase involves the administration of several medications to prepare for the main treatment. These medications include lenalidomide and cyclophosphamide, both taken orally. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.
Additionally, fludarabine is administered intravenously. This phase is crucial for preparing the body for the subsequent main treatment.
Step 2
Main treatment with ARI0002h
The main treatment involves the administration of Cesnicabtagene autoleucel (ARI0002h), which is a type of genetically modified T cell therapy. This is given intravenously and is designed to target and attack specific cancer cells.
The goal of this treatment is to induce a response in the body to fight the plasma cell leukemia.
Step 3
Supportive care
During the treatment, supportive care is provided to manage any side effects. This includes the use of paracetamol for pain relief and tocilizumab to manage inflammation, both administered intravenously.
Regular monitoring is conducted to ensure safety and manage any adverse reactions.
Step 4
Follow-up and monitoring
After the main treatment, regular follow-up appointments are scheduled to monitor the response to the treatment. This includes assessing the overall response rate and checking for any side effects such as cytokine release syndrome or neurological toxicity.
The follow-up period extends up to 24 months, with evaluations at specific intervals to assess the duration of response, progression-free survival, and overall survival.
Step 5
Quality of life assessment
Throughout the trial, the quality of life is assessed using a standardized questionnaire. This helps in understanding the impact of the treatment on daily living and overall well-being.
These assessments are conducted periodically during the first two years after the infusion.

Who can join the trial?

6 criteria

Patients must be between 18 and 75 years old and have been newly diagnosed with **primary plasma cell leukemia**. This means they have 5% or more plasma cells in their blood, which is a type of blood cancer.
The disease must be measurable at diagnosis. This can be done by checking for a **monoclonal component** in the blood or urine, or by measuring **free light chains** in the blood. These are proteins that can indicate the presence of the disease.
Patients must have an **ECOG Performance Status** of 0 to 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Patients should have a life expectancy of more than 3 months.
Patients must have good **venous access**, meaning their veins are suitable for medical procedures, and they should not have any conditions that prevent **lymphoapheresis**, a procedure to collect certain blood cells.
Patients must agree to participate in the study by signing an **Informed Consent Document** after being fully informed about the study.

Who cannot join the trial?

10 criteria

Patients who have any other type of cancer besides plasma cell leukemia cannot participate. Plasma cell leukemia is a rare and aggressive form of blood cancer.
Patients who have received any other experimental treatment for their condition are not eligible.
Patients with severe heart problems, such as heart failure or recent heart attack, are excluded.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals cannot join the study.
Patients with a history of severe allergic reactions to any of the components of the study treatment are not allowed to participate.
Pregnant or breastfeeding women are not eligible for the study.
Patients with uncontrolled high blood pressure or diabetes are excluded.
Patients with a history of drug or alcohol abuse within the past year cannot participate.
Patients who have had a major surgery within the last 4 weeks are not eligible.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Navarra
Pamplona, Spain

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Investigated drugs

ARI0002h (Cesnicabtagene autoleucel) is a type of therapy known as CAR-T cell therapy. It is designed to help the body's immune system fight cancer by using specially modified T cells. These T cells are taken from the patient, altered in the lab to better recognize and attack cancer cells, and then returned to the patient's body. In this trial, ARI0002h targets a specific protein called BCMA, which is found on the surface of cancer cells in patients with primary plasma cell leukemia. The goal of this therapy is to improve the patient's response to initial treatment by enhancing the ability of their immune system to destroy cancer cells.

What is already known about the treatment

Cesnicabtagene autoleucel – This medication is administered as an infusion, specifically designed for patients with primary plasma cell leukemia. It is currently being studied in clinical trials to evaluate its safety and effectiveness. The main therapeutic indication is for the initial treatment of this type of leukemia. At the molecular level, it works by using CAR-T cell technology to target and destroy cancer cells expressing the BCMA protein. It falls under the pharmacological classification of CAR-T cell therapies, which are a type of immunotherapy.

Investigated diseases

Plasma Cell Leukemia – Plasma cell leukemia is a rare and aggressive form of cancer that originates from plasma cells, which are a type of white blood cell responsible for producing antibodies. In this disease, there is an abnormal increase in plasma cells in the blood and bone marrow. It is characterized by the presence of a high number of plasma cells circulating in the bloodstream. As the disease progresses, it can lead to symptoms such as fatigue, bone pain, and increased risk of infections due to the impaired immune system. The disease can also cause complications like anemia and kidney problems. It is considered a more severe form of multiple myeloma, with a rapid progression and distinct clinical features.