Treatment of steroid-resistant chronic graft-versus-host disease with donor-derived regulatory T cells MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Expanded Tregs
Product Code: RegTivex
Pharmaceutical Form: Infusion
INN or Proposed INN: none
Current Sponsor code: RegTiv
Sponsors
Freistaat Bayern represented by University of Regensburg represented by Kaufmännischer Direktor
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria on screening examination have to be fulfilled: • Steroid-refractory moderate to severe cGVHD despite use of two or more agents (failure of 2nd line treatment). Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD (Appendix D) despite the use of prednisone at = 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of other glucocorticoids) without complete resolution of signs and symptoms and continuing moderate to severe cGVHD. • Steroid-dependent cGVHD as indicated if >0.25 mg/kg/d prednisone are needed to prevent cGVHD recurrence or progression on 2nd line treatment or subsequent treatment lines as illustrated by two failed attempts to taper with a more than 8 wks interval • No dose-escalation of glucocorticoids beyond the maximum dose of the prior cGVHD treatment line within 4 wks of enrolment • No addition of other immunosuppressive medications (e.g., calci-neurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrolment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of the drug • ECOG performance status 0-2 (Appendix X, section X) • Participants must have adequate organ function as defined below: Hepatic: Adequate hepatic function (total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: • Age 75 y • No previous steroid therapy • Severe psychiatric disorders • Presumed life expectancy < 4 wks • Lack of informed consent from patient • Donors from outside EU (NMDP, Canadian donor registrar) • Participation in another interventional clinical trial according to the AMG (Arzneimittel¬gesetz) within 30 days prior to inclusion • T cell-depleting antibody therapy within the last 30d before enrolment • Pregnant or nursing woman. Sexually active women with childbearing potential or sexually active male patients unwilling to use an effective form of contraception during participation in the study from time of inclusion until 2 months after Treg therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the safety and MTD Level of in vitro expanded donor regulatory T cells for the Treatment of patients with chronic GVHD; Secondary Objective: To assess the clinical response to Treg treatment To assess immunologic effects of Treg treatment To determine predictors of clinical Response ;Primary end point(s): Toxicity and MTD of Treg-infusion at 4 weeks;Timepoint(s) of evaluation of this end point: 1month after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Feasibility of donor Treg infusion Clinical response of Treg-treated patients at 12 & 24wks after Treg infusion Immunologic effects of Treg treatment within 12 weeks ;Timepoint(s) of evaluation of this end point: wk 1, 4, 8, 12, 24 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Coordination
University Hospital Regensburg
Outcome results
None listed