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AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+

Clinical trials are investigating AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ in adults with ulcerative colitis. This article explains what the study is trying to measure, especially clinical remission and how well the cells reach the target area in the body. The trial is focused on safety and efficacy in a phase 2, single-arm study.

Table of contents

Overview of the trial

The provided clinical trial is studying AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ in adults with ulcerative colitis.[1] The study is designed to see whether the treatment can help people reach clinical remission and to assess in-vivo homing, which means how the transferred cells behave after they are given to the patient.[1]

Who the study is for

This trial is for adults with ulcerative colitis.[1] The source data do not provide more detailed participation rules, so only this target population can be confirmed from the trial record.[1]

Study design and phase

The trial is an interventional study, which means researchers give the study treatment and then measure the results.[1] It is a single-arm study, so there is no separate comparison group listed in the provided data.[1] The study is in Phase 2 and is marked as Authorised.[1]

Main endpoint and what it means

The primary endpoint is the proportion of subjects in clinical remission at week 12 compared with the day of screening.[1] Remission is defined using the modified Mayo score, with a score of 0 for rectal bleeding, 0 or 1 for stool frequency, and 0 or 1 for endoscopy, excluding friability.[1]

In simple terms, the study checks whether symptoms and bowel findings improve enough to meet a strict remission definition.[1] The focus on week 12 shows that the trial is looking at a short-term outcome after treatment.[1]

Trial summary

The trial title describes it as a multicenter, phase 2 study evaluating efficacy and in-vivo homing of adoptively transferred autologous ex-vivo expanded regulatory T cells in adults with ulcerative colitis.[1] The enrollment is 30 participants, and the intervention is listed as AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ for intravenous use.[1] The study’s main goal is to measure clinical remission at week 12, making the remission rate the key outcome for this trial.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2025-520628-11-00Phase 2Ulcerative colitisAuthorised30

FAQ

  • What is being studied in these clinical trials? The trial is studying AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+ in adults with ulcerative colitis. It is looking at whether the treatment can help people reach clinical remission and how the cells behave in the body.
  • Who can take part in the trial? The study is for adults with ulcerative colitis. The trial data do not give more detailed entry rules in the provided information.
  • What phase is the trial? This is a phase 2 trial. Phase 2 studies usually look more closely at how well a treatment works and continue to check safety.
  • What is the main outcome being measured? The main outcome is the proportion of subjects in clinical remission at week 12 using the modified Mayo score. This score checks rectal bleeding, stool frequency, and endoscopy findings.
  • Is this a comparison study with another treatment? No. This is a single-arm trial, which means all participants receive the same study treatment. There is no separate comparison group listed in the trial data.

Sperimentazioni cliniche in corso su AUTOLOGOUS REGULATORY T-CELLS WITH AN IMMUNOPHENOTYPE OF CD4+CD25HI/+FOXP3+

  • Studio sull’efficacia delle cellule T regolatorie autologhe espanse ex-vivo somministrate per via endovenosa in adulti con colite ulcerosa

    Arruolamento non iniziato

    1 1
    Malattie in studio:
    Farmaci in studio:
    Germania

Glossario

  • Ulcerative colitis: A long-term disease that causes inflammation and sores in the colon and rectum. It can lead to bleeding, frequent stools, and urgent bowel movements.
  • Clinical remission: A period when signs and symptoms of the disease are very low or absent. In this trial, it is measured with the modified Mayo score.
  • Modified Mayo score: A scoring system used to measure how active ulcerative colitis is. In this study, it looks at rectal bleeding, stool frequency, and endoscopy results.
  • Rectal bleeding: Bleeding from the rectum, which can be a symptom of ulcerative colitis.
  • Stool frequency: How often a person passes stool. A higher number can mean the disease is more active.
  • Endoscopy: A test that lets doctors look inside the bowel with a camera. It helps show inflammation and healing.
  • Single-arm study: A study in which all participants receive the same treatment. There is no separate control group for comparison.
  • Phase 2: A research stage that looks more closely at whether a treatment works and continues to monitor safety.
  • Interventional study: A trial in which researchers give a treatment and then measure the results.
  • In-vivo homing: How well the transferred cells move to and stay in the body where they are expected to act. This trial includes this as part of what is being studied.

Riferimenti

  1. https://clinicaltrials.gov/study/2025-520628-11-00