Multi-center, single-arm, phase II clinical trial evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis
Key facts
- Where
- Berlin és Erlangen, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországToborzás még nem indult
- Universitaetsklinikum Erlangen AöRErlangen, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Erlangen AöR
- Trial code
- EU 2025-520628-11-00
- Record updated
- 2025. november 5.
- Original description
The primary objective of this study is to evaluate the rate of clinical remission according to the modified Mayo (mMayo) score at week 12 compared to the day of screening (Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy [modified excluding friability]).Read full original descriptionShow less
The primary objective of this study is to evaluate the rate of clinical remission according to the modified Mayo (mMayo) score at week 12 compared to the day of screening (Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy [modified excluding friability]).
Inclusion: Established diagnosis of active UC, with minimum time from diagnosis of ≥ 3 months and confirmed by endoscopy extending 15 cm or more above the anal verge, with a mMayo score of 5-9, including an endoscopic subscore of ≥ 2 (modified to exclude friability from grade 1), WHO performance status of 0, 1 or 2; age ≥ 18 years.
Exclusion: Subjects who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands, cancer, splenectomy or radiation therapy of the spleen, organ allografts; Seriously impaired hematological, hepatic or renal function, major serious illness, evidence for human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2, Treponema pallidum (TPHA), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, subjects who have spent a cumulative period of 1 year or more in the UK between the beginning of 1980 and the end of 1996, subjects who have a family history which places them at risk of developing Creutzfeldt-Jacob disease; suspicion of differential diagnosis including but not limited to Crohn’s enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease associated colitis, microscopic colitis; UC limited to the rectum.