MedTrace Logo

Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease

NCT06075706 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-14

No results posted yet for this study

Summary

The purpose of this trial is the comparative evaluation of overall response rate (ORR) in paediatric participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Visit Day 28 after treatment with MC0518 or first used best available therapy (BAT).

Conditions

  • Steroid-refractory Acute Graft-versus-host Disease

Interventions

BIOLOGICAL

MC0518

MC0518 will be intravenously infused immediately after thawing.

BIOLOGICAL

BAT

BAT including ECP, ATG, etanercept, infliximab or RUX will be administered based on Investigator's decision.

Sponsors & Collaborators

  • medac GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2026-02-11
Completion
2031-06-30

Countries

  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06075706 on ClinicalTrials.gov