RecruitingPHASE1, PHASE2INTERVENTIONAL

CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT

This research study is looking at a new treatment called CD45RA depleted DLI (Donor Lymphocyte Infusion) for patients who have recently had a specific type of stem cell transplant for blood cancer. First, bone marrow stem cells are given after a mild chemotherapy. If there are no issues with the body rejecting the new cells, patients receive the study treatment about a month later. The main goals are to check if this treatment is safe, how well people tolerate it, and to find the best dose. This study is for both children and adults with certain types of blood cancer, and it's being conducted in two parts to ensure safety and effectiveness.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University Hospital Tuebingen

Enrolment target

Start

27 Apr 2023

Estimated completion

01 Dec 2028

Hematologic Malignancy

What is this study about?

This clinical trial is designed for people who have been diagnosed with certain blood cancers, such as leukaemia or lymphoma, and have recently undergone a specific type of stem cell transplant. The stem cell transplant is a standard treatment where healthy stem cells are given, usually from a donor, to replace diseased ones after some mild chemotherapy. This helps the body make new, healthy blood cells.

The main focus of *this study* begins about a month after your stem cell transplant, provided you haven't experienced a problem known as 'Graft-versus-Host Disease' (GVHD). GVHD can happen when the donor's immune cells recognise your body as foreign and attack it. If all is well, you will receive a treatment called CD45RA depleted DLI. This DLI uses special immune cells from your stem cell donor that have been processed to be less likely to cause GVHD, but still able to fight any remaining cancer cells.

The researchers want to understand how safe this CD45RA depleted DLI treatment is and if it causes any unwanted side effects when given after a stem cell transplant. They will also be looking for the most effective dose to give. By adding these special donor immune cells, the aim is to give your body's new immune system an extra boost to recognise and get rid of any cancer cells that might still be present, in the hope of preventing the cancer from returning.

Key takeaways

Tests a new immune cell treatment after stem cell transplant for blood cancers.
Aims to prevent cancer return and understand safety.
Treatment is given about one month after the stem cell transplant, if no severe side effects occur.
Involves regular check-ups to monitor health and treatment effects.
For patients between 8 weeks and 65 years old with specific blood cancers.

Who may be eligible?

To be considered for this study, you must be between 8 weeks old and 65 years old. You need to have been diagnosed with a type of blood cancer like acute myeloid leukaemia (AML), acute lymphoid leukaemia (ALL), Hodgkin's disease, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS)/myeloproliferative syndrome (MPS), or multiple myeloma. Importantly, your cancer should either be in complete or partial remission, or at least stable, before you have your initial stem cell transplant.

There are also some reasons why you might not be able to join. For example, if your cancer is getting worse before the stem cell transplant, or if you've had another stem cell transplant very recently (within the last 3 months). Certain medical conditions, like severe problems with your liver, heart, or brain, or ongoing serious infections, would also prevent you from participating.

You also can't be taking certain powerful medications that affect your immune system or receive other experimental drugs shortly before the study treatment. The medical team will review all your health information to make sure this study is the right fit for you.

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.

Are you between 8 weeks and 65 years old?
Do you have a type of blood cancer (like leukaemia or lymphoma) that is currently stable or in remission?
Have you *not* had another stem cell transplant in the last 3 months?
Do you have good kidney, liver, and heart function?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, the first step is to undergo a standard stem cell transplant from a donor. This involves receiving some mild chemotherapy, followed by an infusion of the donor's stem cells. This part of your treatment is not new to the study.

About 30 days after your stem cell transplant, if everything has gone well and you haven't developed a condition called Graft-versus-Host Disease (where the donor cells attack your body), you'll receive the study treatment, which is an infusion of special immune cells from your donor. This infusion is central to the study. You will have regular check-ups with the medical team, including blood tests and other assessments, to monitor your health, look for side effects, and see how well the treatment is working. The exact number of visits and tests will depend on the phase of the study and your individual response. The researchers will start with a small group of patients and gradually increase the dose of the study treatment in new groups to find the safest and most effective amount. The total length of your participation in the study will be discussed with you by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving an additional treatment that could help prevent your blood cancer from returning after your stem cell transplant. It’s important to remember this is a new approach, and there's no guarantee it will work for everyone. As with any medical treatment, there are potential risks and side effects that will be carefully explained to you by the medical team. These will be closely monitored throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

University Children's Hospital University Clinic Tuebingen
Verified postcode
Tübingen, Germany· Recruiting
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is a 'stem cell transplant'?

A stem cell transplant replaces unhealthy blood-forming cells with healthy ones, often from a donor, to treat certain cancers.

What is 'CD45RA depleted DLI'?

It's a special mixture of donor immune cells, given after a stem cell transplant, designed to fight cancer while hopefully reducing side effects.

What is 'Graft-versus-Host Disease' (GVHD)?

GVHD is when the donor's immune cells attack the patient's body after a transplant. This study treatment is given *if* you don't have GVHD.

Will I get this treatment immediately?

No, the study treatment is given about a month after your initial stem cell transplant, if you haven't experienced GVHD.

What does 'Phase 1' and 'Phase 2' mean?

Phase 1 studies primarily check if a new treatment is safe and to find the right dose. Phase 2 studies then look to see how well it works at that dose.

How to find out more

Wolfgang Bethge, MD, PhD

wolfgang.bethge@med.uni-tuebingen.de +49 7071 29-83176 Official trial record

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