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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Erlangen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2025-08-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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]).

Conditions and MedDRA coding

Ulcerative colitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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
2. age ≥ 18 years

Exclusion criteria 4

1. 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
2. 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
3. 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
4. UC limited to the rectum

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of this study is the proportion of subjects in clinical remission according to the modified Mayo score at week 12 compared to the day of screening (remission defined as the proportion of subjects with Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy [modified excluding friability]).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Erlangen AöR

Sponsor organisation

Universitaetsklinikum Erlangen AöR

Address

Maximiliansplatz 2, Innenstadt Innenstadt

City

Erlangen

Postcode

91054

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

Prof. Dr. Caroline Voskens

Public contact point

Organisation

Universitaetsklinikum Erlangen AöR

Contact name

Prof. Dr. Caroline Voskens

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications