2025-520628-11-00Not yet recruitingPhase 2
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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]).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 May 2025
- Start date
- 1 Jul 2025
- Lead sponsor
- Universitaetsklinikum Erlangen AöR
- Diseases
- Ulcerative colitis
- EU CT number
- 2025-520628-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active ulcerative colitis for at least 3 months. It tests a treatment made from the person's own regulatory T cells.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Active ulcerative colitis, diagnosed at least 3 months ago, confirmed by endoscopy extending 15 cm or more above the anal verge, mMayo score of 5-9, endoscopic subscore of 2 or more, WHO performance status of 0, 1 or 2
Main reasons for not taking part
- Ulcerative colitis limited to the rectum
- Seriously impaired blood, liver or kidney function, or another major serious illness
- Signs of HIV-1, HIV-2, Treponema pallidum, hepatitis B or hepatitis C infection
- Doubt about the diagnosis, for example Crohn's enterocolitis, ischaemic, radiation, infectious or microscopic colitis
- Organ allografts, cancer, or removal of the spleen
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- UC limited to the rectum
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Not yet recruiting |
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.