In short
This article discusses a clinical trial investigating the use of ATreg cells, a type of regulatory T cell activated with GP120, in patients who have undergone haematopoietic stem cell transplantation (HSCT). The study aims to evaluate the safety, tolerability, and potential benefits of ATreg cells in reducing the incidence and severity of acute Graft vs Host Disease (GvHD), a common complication following stem cell transplantation.
At a glance
- Study Type
- Phase Ib/II, prospective, open-label, single-arm, non-randomised, multicentric proof of concept study
- Main Objective
- To assess the safety and tolerability of ATreg cells
- Secondary Objectives
- Evaluate feasibility of generating ATreg cells, assess frequency and severity of acute GvHD, evaluate HSCT engraftment, determine non-relapse mortality, assess long-term follow-up
- Eligibility
- Adults ≥18 years with hematologic malignancies undergoing HSCT with HLA-compatible donors
- Primary Endpoint
- Incidence and severity of ATreg-related Serious Adverse Events within 24h, 3 days, 7 days, and 14 days after application
- Key Secondary Endpoints
- Incidence of acute GvHD, engraftment success, relapse rates, infections, non-relapse mortality
- Follow-up Period
- Up to 6 months after ATreg application
What is ATreg?
ATreg, also known as ATreg-1, is a new type of cell therapy being studied for patients who have undergone a hematopoietic stem cell transplantation (HSCT). This treatment consists of special immune cells called regulatory T cells that have been activated with a substance called GP120. These cells are taken from a healthy donor and prepared in a laboratory before being given to the patient.
Medical Condition Targeted
The main condition that ATreg aims to treat is acute graft versus host disease (GvHD). This is a serious complication that can occur after a stem cell transplant, where the donor's immune cells attack the recipient's body. ATreg is being studied to see if it can reduce how often GvHD happens and how severe it is when it does occur.
Study Objectives
The current clinical trial has several goals:
- To check if ATreg is safe and well-tolerated by patients
- To see if it's possible to create ATreg cells from a healthy donor's blood donation
- To measure how often and how severe acute GvHD is in patients treated with ATreg
- To make sure the stem cell transplant still works properly after ATreg is given
- To track how patients do over a longer period after receiving ATreg
Eligibility Criteria
Not everyone can participate in this study. Here are some key points about who can be included:
- Adults aged 18 or older
- Patients who are planning to have a stem cell transplant from a matched donor
- People with certain blood cancers like leukemia, lymphoma, or multiple myeloma
Some reasons why a person might not be able to participate include:
- Already having signs of acute GvHD
- Being pregnant or breastfeeding
- Having certain infections like HIV, active hepatitis B, or hepatitis C
- Having had another type of cancer in the last 3 years
Treatment Process
The ATreg treatment is given as an infusion, which means it's delivered directly into the bloodstream through a vein. This happens after the patient has received their stem cell transplant. The doctors will closely monitor the patient after the infusion to check for any side effects and to see how well the treatment is working.
Potential Benefits
While it's important to remember that this is still an experimental treatment, researchers hope that ATreg might:
- Reduce the chance of developing acute GvHD
- Make GvHD less severe if it does occur
- Help patients recover better after their stem cell transplant
Safety Considerations
A major focus of this study is to ensure that ATreg is safe for patients. The researchers will be carefully watching for any side effects, especially in the first few weeks after treatment. They'll be looking at things like:
- Any serious adverse events related to ATreg
- How well the stem cell transplant is working
- Any signs of severe infections
Long-term Follow-up
The study doesn't end right after the ATreg treatment. Patients will be monitored for at least 6 months to see how they're doing. During this time, doctors will check for things like:
- Any signs of GvHD
- Whether the original blood cancer comes back
- How many infections the patient gets
This long-term follow-up is crucial to understand both the benefits and any potential risks of ATreg treatment.