NCT07803978

Brief Summary

This study focuses on patients with gastrointestinal-dominant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation. AmiMetosai Injection combined with corticosteroids is administered as first-line treatment. The objective is to evaluate the efficacy and safety of AmiMetosai Injection combined with corticosteroids for the treatment of gastrointestinal aGVHD.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
32mo left

Started May 2026

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
May 2026May 2029

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 4, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

August 19, 2026

Last Update Submit

August 31, 2026

Conditions

Acute Gastrointestinal Graft-versus-host Disease

Keywords

AmiMetosai Injectionumbilical cord mesenchymal stromal cellsmethylprednisolonegastrointestinal acute graft-versus-host diseaseallogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • 28-day overall response rate (ORR) of acute gastrointestinal GVHD

    28-day gastrointestinal aGVHD ORR: CR+PR rate at Day 28 per MAGIC criteria.

    28-day

Secondary Outcomes (2)

  • GVHD-free, relapse-free survival (GRFS)

    1-year post-randomization

  • Cumulative incidence of relapse（CIR）

    1-year post-randomization

Study Arms (2)

Low-dose methylprednisolone combined with AmiMetosai

EXPERIMENTAL

Patients in the experimental group receive low-dose methylprednisolone at a daily dose of 1 mg/kg combined with AmiMetosai Injection. AmiMetosai Injection is administered at a cell dose of 1×10⁶ cells/kg per infusion, twice weekly for an initial 4-week treatment course. Patients with partial response after 4 weeks may receive an additional 4-week extended treatment. Patients with complete response, no response or progressive disease will discontinue AmiMetosai Injection treatment ahead of schedule.

Drug: Amimaitosai injectionDrug: Methylprednisolone

Methylprednisolone monotherapy

ACTIVE COMPARATOR

Participants in the control group receive standard first-line treatment with methylprednisolone at a daily dose of 2 mg/kg. No UC-MSC intervention or other additional immunomodulatory agents will be administered during the trial treatment period.

Drug: Methylprednisolone

Interventions

Amimaitosai injectionDRUG

Amimaitosai injection (1×10⁶ cells/kg per infusion, twice weekly for 4 weeks; may extend to 8 weeks for partial responders).

Low-dose methylprednisolone combined with AmiMetosai
MethylprednisoloneDRUG

Experimental Arm：Methylprednisolone at a daily dose of 1 mg/kg. Active Comparator Arm：Methylprednisolone at a daily dose of 2 mg/kg.

Low-dose methylprednisolone combined with AmiMetosaiMethylprednisolone monotherapy

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and CML in chronic phase
  • Availability of HLA-matched sibling donors, unrelated donors, or haploidentical donors
  • Age 14 years and older
  • Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal
  • Kidney function: creatinine ≤ upper limit of normal
  • No uncontrolled infections or severe psychiatric disorders
  • Performance status 0-2 (ECOG)
  • Signed informed consent
  • Patients with acute gastrointestinal GVHD after transplantation (according to MAGIC criteria)

You may not qualify if:

  • No suitable allogeneic donor
  • Non-gastrointestinal GVHD as the main manifestation
  • Either donor or recipient is pregnant
  • Psychiatric illness or other conditions preventing protocol compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

August 19, 2026

First Posted

September 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

September 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)