For Patients and Donors
Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with virus-specific T cells:
A phase III, prospective, multi-national clinical trial
TRACE is the first multi-national clinical trial to prove efficacy and safety of Adoptive T-cell transfer in immunocompromised individuals. Until now, 181 out of 246 (74%) patients with various viral diseases have been successfully treated with virus-specific T cells. TRACE will provide data, ethical and regulatory approvals and logistic infrastructure to build the basis for bringing adoptive transfer of virus-specific T cells into clinical routine.
From Bench To Bedside
Clinical trials are necessary to obtain or expand our knowledge about the efficacy and tolerability of medicinal products. Therefore, the legislature has stipulated that new medicinal products must be clinically tested. As required by law, the TRACE trial has been approved by the responsible authority and has been issued a favourable opinion by independent ethics committees.
TRACE ("TRansfer of Adenovirus, Cytomegalovirus and Epstein-Barr virus-specific T cells") is
- Phase III
- randomized Placebo-controlled and
The TRACE trial will be conducted in about 35 clinical centres of six European countries: Belgium, France, Germany, Italy, the Netherlands and UK. A total of approximately 150 children as well as adults are expected to participate. The study is coordinated by the Dr. von Hauner Children's Hospital (Sponsor) and funded by the European Commission.
The aim of the TRACE trial is the development of individualized medicine. T-cell immunity is one of the most individualized aspects of human physiology. Using adoptive transfer of mulitvirus-specific T cells will enable the patient to protect himself instead of receiving toxic antiviral chemotherapy. T-cell therapy is "help to help themselves".
European patient health will benefit through a safe, curative and innovative individualized treatment option, that has not been available for the majority of eligible patients in the past. Further the project will contribute evidence-based data on this treatment:
- reduced rate of CMV, EBV or AdV infections/reactivations
- reduced frequency of hospitalizations
- reduced medication intake