TREATS1 - CTA - V01
Research type
Research Study
Full title
A phase I/IIa, multicentre, randomised, masked, placebo-controlled, ascending dose and multi-injection study to evaluate the safety and the efficacy of Col-Treg (autologous collagen type II-specific Treg cells) in patients with active non-infectious uveitis (Treg in Eye Autoimmunity Treatment Study: TREATS1)
IRAS ID
177276
Contact name
Andrew Dick
Contact email
Eudract number
2014-005524-94
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
TREATS1 is planned to be a multicentre (approximately 9 sites in 5 European countries), randomised, masked, placebo-controlled, ascending dose study, with 2 injections to evaluate the safety and the efficacy of Col-Treg in patients with active non-infectious uveitis. Col-Treg is not a conventional drug, it is an autologous cell therapy and has the status of Advanced Therapy Medicinal Product. In addition, Col-Treg has been granted orphan designation in Europe for the treatment of non-infectious uveitis. Col-Treg consists of regulatory T cells derived from the participants own blood. These cells of interest will be isolated after a standard venipuncture, amplified in vitro before the patients are injected with them. Regulatory T cells are components of the immune system and play an important regulatory and anti-inflammatory role which has been shown by the scientific community to be beneficial in relation to inflammatory diseases including non-infectious uveitis. Patients aged 18 to 70 years whose disease is currently in active phase and resistant to all existing treatments will be targeted providing they meet all the eligibility criteria. The sites selected are major referal centers for non-infectious uveitis, with good connection with other sites and therefore an enlarger potential patient population. The study will consist of an approximately 15-week pre-treatment period during which the patients will be screened and Col-Treg produced, a 24-week follow-up period (TREATS1-M) during which the patients will received the 2 masked injections and an additional 2.7-year safety follow-up period.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0043
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion