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Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Safety, Tolerability and Feasibility of Treatment with GP120-activated Regulatory T cells (ATreg) Early After Haematopoietic Stem Cell Transplantation (HSCT) to Reduce the Incidence and Severity of Acute Graft vs Host Disease (GvHD)

This study is investigating a new treatment called ATreg for individuals with leukaemia who have recently undergone a stem cell transplant. The main goal is to understand if ATreg is safe and well-tolerated by patients in the early stages after their transplant. Researchers will closely monitor for any side effects in the first few weeks after giving the ATreg treatment. A key focus is to see if ATreg can help reduce the chances of developing Graft vs Host Disease (GvHD). GvHD is a serious complication where the new, healthy stem cells from the donor start attacking the patient's own body. By finding ways to prevent or lessen GvHD, this study hopes to improve the recovery and long-term health of patients following this life-saving procedure.

At a glance

Status
Ongoing, recruiting
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
ActiTrexx GmbH
Enrolment target
10
Start
02 Oct 2024

What is this study about?

When someone with leukaemia has a stem cell transplant, they receive healthy new cells from a donor. This is a powerful treatment, but sometimes the new cells don't recognise the patient's body and start to attack it. This serious problem is called Graft versus Host Disease, or GvHD.

This study is testing a new treatment called ATreg (which stands for GP120-activated Regulatory T cells). These are special cells from the immune system that are designed to help calm down the donor cells and stop them from attacking the patient's body. The aim is to give these ATreg cells early on after a stem cell transplant to see if they can prevent or reduce the severity of GvHD.

This is a 'Phase I and Phase II' study, which means it's one of the first times this treatment is being given to people. The main focus is on safety – checking for any side effects and how well people tolerate the treatment. Researchers will also be looking to see if it makes a difference to how often GvHD occurs and how severe it is, as well as checking for other important outcomes like infections and how well the new cells settle in.

Key takeaways

  • This study is for adults with leukaemia having a stem cell transplant.
  • It tests a new treatment (ATreg) to prevent Graft versus Host Disease (GvHD).
  • The main focus is on the safety of the ATreg treatment.
  • Researchers will also track how well patients recover and if GvHD is reduced.
  • Participation involves close monitoring and regular hospital visits after treatment.

Who may be eligible?

This study is open to adults aged 18 and over, of any sex. You would typically be someone who has been diagnosed with leukaemia and is scheduled to have, or has recently had, a stem cell transplant.

There will be specific health requirements and other medical checks to make sure the study is a good fit for you and that taking part is safe. For example, your general health, other medical conditions, and any medications you are taking will all be carefully considered.

The research team will discuss all the details with you to confirm if you meet the specific criteria for joining the study. This is to ensure the treatment is suitable for your individual health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of leukaemia?
  3. Are you having or have you recently had a stem cell transplant?
  4. Are you able to attend regular hospital appointments for monitoring?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the ATreg treatment soon after your stem cell transplant. Researchers will then closely monitor your health for a period of time. This will involve several visits to the hospital for checks, which may include blood tests to look at your aGVHD symptoms, and to see how your body is responding to the treatment and the transplant. You will also be monitored for any side effects. These assessments will be more frequent in the first few weeks (e.g., within 24 hours, 3 days, 7 days, and 14 days after receiving ATreg), and then continue periodically for up to 6 months to track your progress, particularly concerning GvHD, infections, and how well your new blood cells are developing. The exact total duration of your participation, including follow-up, will be detailed by the study team.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a new and innovative treatment that might reduce the risk or severity of GvHD, which is a serious complication after a stem cell transplant. However, as ATreg is a new treatment, there are also potential risks, including side effects from the treatment itself, which will be carefully monitored. The research team will explain all known or potential risks in detail. Remember, joining a clinical study is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Germany

Common questions

What is leukaemia?

Leukaemia is a type of cancer that affects the blood and bone marrow, the spongy tissue inside bones where blood cells are made.

What is a stem cell transplant?

It's a medical procedure where unhealthy blood-forming cells are replaced with healthy ones, often from a donor, to help treat certain cancers like leukaemia.

What is GvHD?

GvHD stands for Graft versus Host Disease. It's a complication after a stem cell transplant where the new, healthy donor cells see the patient's body as 'foreign' and start to attack it.

What are 'ATreg cells'?

ATreg cells are special immune cells that are being tested to see if they can help calm down the donor cells and prevent them from causing GvHD.

Will I definitely get the new ATreg treatment?

This study is testing the new treatment, so you would receive ATreg. The main goal is to check its safety and early effects in patients.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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