Clinical trial • Phase II • Gastroenterology
AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ for Ulcerative colitis
Phase II trial of AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ for Ulcerative colitis. open-label. 30 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 21-08-2025
Trial design
open-label Phase II trial across 2 sites in Germany.
- Open Label
- Yes
- Target Sample Size
- 30
Eligibility
Recruits 30 The CTIS record indicates isVulnerablePopulationSelected = true. Subject information and informed consent documents are listed (L2_Subject_Card_ER-TREG-02; L1_SIS_ICF_ER-TREG-02). No further details on consent/assent procedures or handling of vulnerable participants are provided in the available JSON..
- Vulnerable Population
- The CTIS record indicates isVulnerablePopulationSelected = true. Subject information and informed consent documents are listed (L2_Subject_Card_ER-TREG-02; L1_SIS_ICF_ER-TREG-02). No further details on consent/assent procedures or handling of vulnerable participants are provided in the available JSON.
Inclusion criteria
- {"criterion_text":"- 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\n- age ≥ 18 years"}
Exclusion criteria
- {"criterion_text":"- 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\n- 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\n- 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\n- UC limited to the rectum"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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]).","definition_or_measurement_approach":"Clinical remission at week 12 versus screening according to the modified Mayo (mMayo) score; remission defined as Mayo subscores of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy (modified excluding friability)."}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent obtained from adult participants (age ≥ 18). Subject information and informed consent forms are listed in trial documents: 'L2_Subject_Card_ER-TREG-02' and 'L1_SIS_ICF_ER-TREG-02'. No further details on assent, consent providers beyond adults, or available languages are provided in the JSON.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 30
Germany
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 05-11-2025
- Processing Time Days
- 107
- Number Of Sites
- 2
- Number Of Participants
- 30
Sites
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Department of Gastroenterology, Pneumology and Endocrinology
- Principal Investigator Name
- Markus Neurath
- Principal Investigator Email
- markus.neurath@uk-erlangen.de
- Contact Person Name
- Markus Neurath
- Contact Person Email
- markus.neurath@uk-erlangen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Gastroenterology, Infectious Diseases and Rheumatology
- Principal Investigator Name
- Britta Siegmund
- Principal Investigator Email
- britta.siegmund@charite.de
- Contact Person Name
- Britta Siegmund
- Contact Person Email
- britta.siegmund@charite.de
Sponsor
Primary sponsor
- Full Name
- Universitaetsklinikum Erlangen AöR
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- Treg (autologous regulatory T-cells with an immunophenotype of CD4+CD25HI/+FOXP3+)
- Active Substance
- AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+
- Modality
- Cell therapy
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- prodAuthStatus=1
- Maximum Dose
- maxDailyDoseAmount 5000000 IU/kg; maxTotalDoseAmount 10000000 IU/kg
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