Not yet recruitingRare disease

Study on Siplizumab, Cyclophosphamide, and Splenectomy for Preventing Liver Transplant Rejection in Patients Receiving a Deceased Donor Liver

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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 treatment for patients who have received a liver transplant from a deceased donor. The main goal is to see if a specific treatment can help the body accept the new liver without the need for long-term medication to suppress the immune system. The treatment being tested includes a medication called siplizumab, which is an anti-CD2 antibody, used in combination with another drug called cyclophosphamide and a surgical procedure known as splenectomy, which involves removing the spleen.

The study aims to find out if this combination can help the body tolerate the new liver, reducing the risk of the immune system attacking it, a condition known as liver allograft rejection. Participants in the study will receive the treatment and be monitored over a period of time to see if they can remain free from the usual medications that suppress the immune system. Some participants will receive a placebo instead of the active treatment to compare the results.

The study will last for up to 60 months, during which participants will undergo regular check-ups and tests to monitor their health and the function of the transplanted liver. The researchers will look at various outcomes, such as the number of patients who can stop taking immunosuppressive drugs and the occurrence of any complications like acute rejection of the liver. The ultimate aim is to improve the quality of life for liver transplant recipients by potentially reducing their dependence on long-term medication.

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, the patient must meet specific criteria, including being between 18 and 70 years old, having a MELD score of less than 30, and being EBV sero-positive and SARS-CoV-2 negative.
The patient must have a stable cardio-pulmonary status and be eligible for a liver transplant from a deceased donor.
Step 2
Pre-transplant preparation
Before the liver transplant, the patient will undergo a series of evaluations to ensure readiness for the procedure.
The patient will be informed about the use of siplizumab, an anti-CD2 antibody, which will be administered intravenously as a solution for injection or infusion.
Step 3
Liver transplant and initial treatment
The liver transplant is performed using a deceased donor organ that is ABO compatible.
Following the transplant, the patient will receive siplizumab in combination with cyclophosphamide and undergo a splenectomy to help induce tolerance to the new liver.
Step 4
Post-transplant monitoring
The patient will be closely monitored for any signs of liver rejection and overall health status.
Regular assessments will be conducted to evaluate the effectiveness of the treatment and the patient's response to the new liver.
Step 5
Immunosuppression evaluation
The primary goal is to determine if the patient can be free from immunosuppression by Month 30 post-transplant.
Secondary evaluations include monitoring for acute rejection, graft loss, or death, and assessing the patient's ability to remain off immunosuppression for at least 12 months.
Step 6
Long-term follow-up
The study will continue for up to 60 months, with ongoing assessments to ensure the patient's health and the success of the liver transplant.
The final evaluations will be conducted to determine the long-term outcomes of the treatment regimen.

Who can join the trial?

6 criteria

Adults aged between 18 and 70 years old who are receiving a liver transplant from a deceased donor that is **ABO compatible**. This means the blood type of the donor and recipient are compatible.
A **MELD score** of less than 30. The MELD score is a number that helps doctors understand how severe liver disease is. It should be less than 30 based on a recent evaluation done within 60 days before the screening.
A stable heart and lung condition, as judged by the doctor, and eligible for transplantation according to local rules.
**EBV sero-positive**. This means the person has been exposed to the Epstein-Barr virus in the past and has antibodies against it.
Negative for **SARS-CoV-2**, which means the person does not have the virus that causes COVID-19.
Male participants must agree to use barrier contraception, like a condom, and not father a child until 12 weeks after the last dose of a medication called MMF.

Who cannot join the trial?

9 criteria

Patients who are not receiving a liver transplant from a deceased donor.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have medical conditions that could interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to medications used in the study.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse that could affect their ability to participate in the study.
Patients who have any other condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Verified
Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Siplizumab
is an anti-CD2 antibody used in this trial. It is designed to help the body accept a transplanted liver by reducing the immune system's response against the new organ. This medication aims to promote tolerance, meaning the body is less likely to reject the transplanted liver.
Cyclophosphamide
is a medication that suppresses the immune system. In this trial, it is used to help prevent the body from attacking the transplanted liver. By weakening the immune response, cyclophosphamide supports the acceptance of the new organ.
Splenectomy
is a surgical procedure that involves the removal of the spleen. In the context of this trial, it is performed to help reduce the immune system's activity, further aiding in the acceptance of the transplanted liver.

Siplizumab

What is already known about the treatment

Siplizumab – Siplizumab is administered intravenously and is currently being studied in clinical trials for its potential to prevent liver transplant rejection. It is an experimental medication, not yet widely used in standard medical practice. The main therapeutic indication is to prevent rejection in liver transplant patients by inducing immune tolerance. Siplizumab works by targeting the CD2 protein on immune cells, which helps modulate the immune response to prevent the body from attacking the transplanted liver. It is classified as a monoclonal antibody.

Investigated diseases

Liver Allograft Rejection – This condition occurs when the immune system of a liver transplant recipient attacks the transplanted liver, viewing it as a foreign object. The rejection process can be acute, happening shortly after the transplant, or chronic, developing over a longer period. Symptoms may include jaundice, fever, and abdominal pain, indicating that the liver is not functioning properly. The immune response involves various cells and antibodies that target the liver tissue, leading to inflammation and potential damage. Over time, if not managed, this can affect the liver's ability to function and may require medical intervention to prevent further complications.