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Tests regulatory T cell therapy in adults with ulcerative colitis

Tests patients' own expanded regulatory T cells, given back, in adults with ulcerative colitis.

Key facts

Who runs it
Universitaetsklinikum Erlangen AöR
Where
Berlin and Erlangen, GermanySee the 2 sites
Registry title
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
Status
Not yet recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 Jul 2025
Expected to end
31 Aug 2029
Type of study
Interventional
Record updated
5 November 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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 (5.9 in) 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

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyNot yet recruiting

About the trial

What the trial wants to find out

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]).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests regulatory T cell therapy in adults with ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
5 November 2025