# A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease

> **NCT07568535** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Mesoblast, Ltd.** · enrollment: 180 (estimated)

## Conditions studied

- GVHD - Graft-Versus-Host Disease

## Interventions

- **DRUG:** Remestemcel-L-rknd
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT07568535
- **Lead sponsor:** Mesoblast, Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2026-08-31
- **Primary completion:** 2028-02-28
- **Final completion:** 2028-07
- **Target enrollment:** 180 (ESTIMATED)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07568535

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07568535, "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT07568535. Licensed CC0.

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