Ongoing Clinical Trials for Liver Transplant Rejection
Currently, there is 1 ongoing clinical trial investigating new treatments for liver transplant rejection. This trial is testing an innovative personalized cell therapy approach designed to help prevent rejection of transplanted livers. The trial is being conducted in Belgium and Spain.
Clinical trial locations
- Belgium
- Spain
Study of QEL-001 (CAR T regulatory cell therapy) to prevent liver transplant rejection in patients with HLA-A2 positive donor organ
This trial is testing an innovative approach to preventing rejection in liver transplant patients. The treatment, called QEL-001, uses a personalized cell therapy made from the patient’s own immune cells.
What is the main goal of this trial?
The primary purpose of this study is to evaluate whether QEL-001 is safe and well-tolerated by patients who have received a liver transplant. The treatment involves taking immune cells from the patient’s blood, modifying them in a laboratory to recognize specific proteins on the transplanted liver, and then returning them to the patient through an intravenous injection. The study will also explore whether this treatment might allow patients to reduce or eventually stop taking their regular anti-rejection medications.
What is QEL-001?
QEL-001 is an experimental cell therapy that uses modified T regulatory cells from the patient’s own immune system. These cells are specially engineered in a laboratory to target specific proteins called HLA-A2 that are present on the transplanted liver tissue. The idea is to teach the immune system to better accept the transplanted organ, rather than attacking it. Each treatment is specifically made for each individual patient using their own cells, making it a truly personalized therapy. The treatment is given as a single infusion.
Who can participate in this trial?
This study is designed for patients who meet several specific criteria. Participants must be between 18 and 75 years old and able to understand and sign consent documents. They must have received their liver transplant between 1 and 5 years ago from a donor who was HLA-A2 positive, while the patient themselves must be HLA A2/A28 negative. HLA refers to specific proteins on cells that help match organ donors and recipients.
Participants must have been taking stable anti-rejection medications for at least 12 weeks before starting the study and must not have experienced any rejection episodes in the last 12 months, with the exception of early rejection in the first 3 months after transplant. Previous rejections that required special antibody treatment would exclude a patient from participating.
The trial requires that patients have normal liver function tests, with specific liver enzymes below certain levels. Adequate kidney function is also necessary, with an eGFR of at least 40 mL/min/1.73 m². Blood cell counts, including white blood cells, red blood cells, and platelets, must be within normal ranges. Participants must be able to perform daily activities without significant limitations and must agree to use effective birth control during the study and for 12 months afterward. Women who can become pregnant must have a negative pregnancy test before starting treatment.
Who cannot participate in this trial?
Several conditions exclude patients from participating in this study. Pregnant or breastfeeding women cannot participate, nor can individuals with a history of allergic reactions to similar medications. Active infections or serious medical conditions that could interfere with the study are also exclusion factors.
Patients who have received organ transplants other than the liver, or who are using immunosuppressive medications not approved by the study team, cannot join the trial. Those who have participated in another clinical trial within the past 30 days are also excluded.
Medical conditions that prevent participation include known HIV infection, active or chronic hepatitis B or C infection, severe kidney dysfunction, and uncontrolled high blood pressure. A history of cancer within the past 5 years excludes patients, with the exception of successfully treated skin cancer. Additionally, a history of substance abuse within the past 5 years or mental conditions that could affect the ability to provide informed consent are exclusion criteria.
What does participation involve?
Participation in this trial involves several phases. Initially, blood samples are collected from the patient to create the personalized QEL-001 treatment. Medical tests are performed to check liver function, kidney function, and blood cell counts. Before receiving the treatment, patients receive a medication called rATG to prepare the immune system.
The QEL-001 treatment is given as a single dose through an intravenous injection. After treatment, patients are monitored closely for the first 28 days to identify any possible side effects, with regular checks of liver function. Long-term follow-up continues for one year after treatment, with regular blood tests and additional assessments at specific time points. During this period, immunosuppression medication may be gradually reduced if the patient’s condition allows.
Summary
This single trial represents an emerging approach in transplant medicine, focusing on personalized cell therapy rather than traditional immunosuppressive medications. The study is being conducted in two European countries, Belgium and Spain, and targets a specific subset of liver transplant patients based on tissue matching characteristics. The innovative nature of QEL-001 as an autologous CAR T regulatory cell therapy demonstrates the growing interest in using modified immune cells to prevent organ rejection. The trial’s focus on potentially reducing or eliminating the need for conventional anti-rejection medications could represent an important advancement for patients who have undergone liver transplantation.
