Acute Gastrointestinal Graft-versus-host DiseaseEarly Phase 1NCT07803978
Prospective Randomized Controlled Study: Amimaitosai Injection Combined With Corticosteroids for Gastrointestinal aGVHD
A Early Phase 1 study testing Amimaitosai injection and Methylprednisolone in people with Acute Gastrointestinal Graft-versus-host Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Gastrointestinal Graft-versus-host Disease
- What is being tested?
- Amimaitosai injection and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- Performance status 0-2 (ECOG)
- Signed informed consent
- Patients with acute gastrointestinal GVHD after transplantation (according to MAGIC criteria)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Aprospective, Randomized, Controlled Study of Amimaitosai Injection Combined With Corticosteroids for the Treatment Ofgastrointestinal Acute Graft-versus-host Disease
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.
Read the detailed description
This study focuses on patients with newly developed gastrointestinal-predominant aGVHD after allogeneic hematopoietic stem cell transplantation. The experimental group receives methylprednisolone 1 mg/kg/d combined with AmiMetosai Injection (1×10⁶ cells/kg, twice weekly for 4 weeks; extended to 8 weeks for partial responders). The control group receives methylprednisolone 2 mg/kg/d monotherapy. The primary endpoint is the Day 28 overall response rate. Secondary endpoints include GVHD-free relapse-free survival and cumulative incidence of relapse. Safety outcomes include adverse events, grade 3-4 toxicities, and abnormal laboratory parameters. Previous studies have reported that mesenchymal stromal cells are safe and effective for steroid-refractory gastrointestinal aGVHD. In this study, the combination is administered with the aim of improving treatment response and reducing corticosteroid-related toxicity.
- Being tested
- Amimaitosai injection, Methylprednisolone
- Keywords
- AmiMetosai Injection, umbilical cord mesenchymal stromal cells, methylprednisolone, gastrointestinal acute graft-versus-host disease, allogeneic hematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amimaitosai injectionDrug
Amimaitosai injection (1×10⁶ cells/kg per infusion, twice weekly for 4 weeks; may extend to 8 weeks for partial responders).
Experimental Arm：Methylprednisolone at a daily dose of 1 mg/kg. Active Comparator Arm：Methylprednisolone at a daily dose of 2 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amimaitosai injection; Drug: 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. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day overall response rate (ORR) of acute gastrointestinal GVHD
28-day gastrointestinal aGVHD ORR: CR+PR rate at Day 28 per MAGIC criteria.
Measured: 28-day
Secondary outcomes (2)
GVHD-free, relapse-free survival (GRFS)
GRFS is a composite endpoint measuring the time from treatment initiation to the first occurrence of grade 3-4 acute GVHD, chronic GVHD requiring systemic immunosuppression, hematological relapse, or all-cause death. Patients without any above events are censored at the last valid follow-up date.
Measured: 1-year post-randomization
Cumulative incidence of relapse（CIR）
Competing-risk endpoint for hematological relapse from randomization, with non-relapse death as competing risk.
Measured: 1-year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 May 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Dou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803978
- Sponsor's protocol ID
- S2026-535-01
- Status last verified
- May 2026
- First submitted
- 19 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprospective, Randomized, Controlled Study of Amimaitosai Injection Combined With Corticosteroids for the Treatment Ofgastrointestinal Acute Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT07803978
- Acronym / sponsor ID
- S2026-535-01
- Keywords
- AmiMetosai Injection, umbilical cord mesenchymal stromal cells, methylprednisolone, gastrointestinal acute graft-versus-host disease, allogeneic hematopoietic stem cell transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study focuses on patients with newly developed gastrointestinal-predominant aGVHD after allogeneic hematopoietic stem cell transplantation. The experimental group receives methylprednisolone 1 mg/kg/d combined with AmiMetosai Injection (1×10⁶ cells/kg, twice weekly for 4 weeks; extended to 8 weeks for partial responders). The control group receives methylprednisolone 2 mg/kg/d monotherapy. The primary endpoint is the Day 28 overall response rate. Secondary endpoints include GVHD-free relapse-free survival and cumulative incidence of relapse. Safety outcomes include adverse events, grade 3-4 toxicities, and abnormal laboratory parameters. Previous studies have reported that mesenchymal stromal cells are safe and effective for steroid-refractory gastrointestinal aGVHD. In this study, the combination is administered with the aim of improving treatment response and reducing corticosteroid-related toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose methylprednisolone combined with AmiMetosai | Experimental | Drug: Amimaitosai injection, Drug: MethylprednisolonePatients 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. |
| Methylprednisolone monotherapy | Active comparator | Drug: MethylprednisoloneParticipants 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amimaitosai injectionAmimaitosai injection (1×10⁶ cells/kg per infusion, twice weekly for 4 weeks; may extend to 8 weeks for partial responders). | Drug | Low-dose methylprednisolone combined with AmiMetosai |
| MethylprednisoloneExperimental Arm：Methylprednisolone at a daily dose of 1 mg/kg. Active Comparator Arm：Methylprednisolone at a daily dose of 2 mg/kg. | Drug | Low-dose methylprednisolone combined with AmiMetosai, Methylprednisolone monotherapy |
Primary outcome
28-day overall response rate (ORR) of acute gastrointestinal GVHD
Time frame: 28-day
28-day gastrointestinal aGVHD ORR: CR+PR rate at Day 28 per MAGIC criteria.
2 secondary outcomes
GVHD-free, relapse-free survival (GRFS)
Time frame: 1-year post-randomization
Cumulative incidence of relapse（CIR）
Time frame: 1-year post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amimaitosai injection and Methylprednisolone in people with Acute Gastrointestinal Graft-versus-host Disease, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day overall response rate (ORR) of acute gastrointestinal GVHD (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.