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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520628-11-00

Enrollment

Registered

2025-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Brief summary

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]).

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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]).	—

Countries

Germany

Outcome results