Treatment of severe gastrointestinal graft-versus-host disease with regulatory T cells

Treatment of steroid resistant severe acute gastrointestinal graft-versus-host disease with in vitro expanded donor-derived regulatory T cells A prospective open-label one-armed non-randomized multicenter early phase II proof of principle study - Treg Therapy

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002685-12-DE

Enrollment

Registered

2012-10-29

Start date

2013-05-22

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Steroid resistant severe acute gastrointestinal graft-versus-host disease MedDRA version: 20.0 Level: LLT Classification code 10068908 Term: AGVHD System Organ Class: 100000004870

Interventions

Product Code: Expanded Tregs Pharmaceutical Form: Infusion INN or Proposed INN: expanded Treg Other descriptive name: expanded Treg Concentration unit: million organisms/ml million organisms/millilitr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histology-proven GVHD - Clinical stage 2-4 acute gastrointestinal GVHD with or without other GVHD manifestations (overall GVHD grade III-IV) - Disease resistance to steroid treatment (at least 1 mg/kg bw) - Male and female patients, age 18 - 70y - Written informed consent of patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

Exclusion criteria: - Age 70 y - No previous steroid therapy (first-line treatment) - No previous second-line therapy - Severe psychiatric disorders - Presumed life expectancy < 4 wks - Lack of informed consent - Pregnant or nursing woman - Patients included in other clinical trials interfering with the present study - Donors from outside EU

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine whether the transfusion of in vitro expanded donor regulatory T cells improves severe gastrointestinal acute GVHD;Secondary Objective: Secondary objectives : To determine - overall survival and non-relapse mortality at 6 months after Treg cell therapy - the influence of Treg cell therapy on other sites of GVHD manifestation than the gastrointestinal tract - the impact of Treg cell transfusion on reactivated viruses, de novo virus reactivation or infection and the occurrence of other life-threatening (°IV WHO) infections - the frequency of Treg cells in peripheral blood of patients before and at serial time points after Treg treatment ;Primary end point(s): Change in gastrointestinal GVHD stage two months after Treg treatment according to modified Glucksberg criteria;Timepoint(s) of evaluation of this end point: 2 months after therapy.	—

Measure

Time frame

Main Objective: To examine whether the transfusion of in vitro expanded donor regulatory T cells improves severe gastrointestinal acute GVHD;Secondary Objective: Secondary objectives : To determine - overall survival and non-relapse mortality at 6 months after Treg cell therapy - the influence of Treg cell therapy on other sites of GVHD manifestation than the gastrointestinal tract - the impact of Treg cell transfusion on reactivated viruses, de novo virus reactivation or infection and the occurrence of other life-threatening (°IV WHO) infections - the frequency of Treg cells in peripheral blood of patients before and at serial time points after Treg treatment ;Primary end point(s): Change in gastrointestinal GVHD stage two months after Treg treatment according to modified Glucksberg criteria;Timepoint(s) of evaluation of this end point: 2 months after therapy.

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Secondary

Measure	Time frame
Secondary end point(s): - OS and NRM at 2 and 6 months after Treg treatment - Relapse of underlying disease at 6 months after Treg therapy in patients transplanted for heamatologic malignancies - GVHD status according to NIH criteria before and at 1, 2 and 6 months after Treg therapy - aGVHD activity index before and 1, 2 and 6 months after Treg treatment - Quantitative titer for reactivated viruses before and 2, 4 and 8 wks after Treg treatment and de novo virus reactivation or infection - De novo °IV infections after Treg therapy according to WHO classification - Frequency of Treg cells (defined as CD4+CD25+FOXP3+ by FACS) in peripheral blood at serial time points;Timepoint(s) of evaluation of this end point: .	—

Measure

Time frame

Secondary end point(s): - OS and NRM at 2 and 6 months after Treg treatment - Relapse of underlying disease at 6 months after Treg therapy in patients transplanted for heamatologic malignancies - GVHD status according to NIH criteria before and at 1, 2 and 6 months after Treg therapy - aGVHD activity index before and 1, 2 and 6 months after Treg treatment - Quantitative titer for reactivated viruses before and 2, 4 and 8 wks after Treg treatment and de novo virus reactivation or infection - De novo °IV infections after Treg therapy according to WHO classification - Frequency of Treg cells (defined as CD4+CD25+FOXP3+ by FACS) in peripheral blood at serial time points;Timepoint(s) of evaluation of this end point: .

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Countries

Germany

Contacts

Public ContactClinical Trial Coordination

University Hospital Regensburg

pavla.schlosser@ukr.de00499419445149

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026