1. Learning about and checking your eligibility for participation
On our website, you will find relevant information on the blood cancer study. Take your time to learn more about the trial and its goals.
The „Check eligibility now“ option takes you to a non-binding questionnaire, which determines whether you are eligible for participation regarding the most important criteria. Some specific medical criteria for suitability for the clinical trial are checked during the first screening visit at the clinical trial site.
2. Scheduling an appointment
At the end of the questionnaire, you can share your contact details. Our Patient Information Service will then contact you as soon as possible.
In a personal telephone interview, we will discuss the next steps with you and schedule an appointment at your nearest clinical trial site.
3. Visiting the clinical trial site: the study physician educates you
During your first visit to the clinical trial site, your study physician will explain all the details to you in a personal consultation. Your eligibility for the clinical trial will be thoroughly checked once again. You will have the opportunity to ask any questions you would like to clarify before participating. You will also receive all information in written form to read at home. Take all the time you need to do this or study the information at home together with your family, friends, or trusted persons. Once you have understood everything and have decided to participate in the clinical trial, you and the study physician will sign the informed consent form. From now on, you are enrolled in the clinical trial.
4. After your consent: start of the clinical trial and first screening visit
With your written consent, the clinical trial starts for you. First, a few essential medical examinations are conducted to check whether your participation in the clinical trial is safe enough from a medical point of view. This includes taking blood and bone marrow samples to perform two specific genetic tests that are crucial for your eligibility.
5. Preparing for treatment
Once eligibility has been confirmed, health care professionals will perform leukapheresis, i.e., collect white blood cells from you. The study drug will be made from this collection. Leukapheresis is similar to dialysis. Blood is passed through a machine in which white blood cells are isolated explicitly in the process. The collected cells are then modified with the receptor in a unique production process that takes several weeks.
6. Second screening visit and pre-treatment
When TCR therapy has been successfully established, a second screening visit is required. In addition to this, pre-treatment is commenced, which may require an inpatient stay at your trial site. If you still meet all the criteria, you will receive TCR therapy.
In this clinical trial, safety, tolerability, and dosage will first be assessed in three to four groups receiving different doses. This means you will be assigned to one of these groups. Your study physician will tell you in which dosage group you will be. The clinical trial is performed unblinded. This means that everybody, including you, your study physician, and the sponsor, know which treatment you will be receiving.
7. Treatment phase
This phase lasts about seven days and is conducted on an inpatient basis at your clinical trial site, i.e., you remain hospitalized during this time. The T cells which have been previously collected and modified will be given back to you in an infusion that takes less than 30 minutes. From now on, the therapy may start to show an effect. During these days, you will receive intensive care and close medical supervision.
8. Follow-up phase with a final visit
For follow-up and control visits, you will need to come to your clinical trial site at regular intervals during the following 12 months. Blood and bone marrow samples will also be taken.
In total, this clinical trial will take about 15 months.
