An Early Phase 1 interventional study of Amimaitosai injection and Methylprednisolone in Acute Gastrointestinal Graft-versus-host Disease, sponsored by Chinese PLA General Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Chinese PLA General Hospital · Early Phase 1, Interventional, and Treatment
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Among 81 studies in Graft vs Host Disease with a site in China — 38 open to participants now, 43 under way, 8 of them phase 3. Graft vs Host Disease · China.
Among the 81 studies in Graft vs Host Disease with a site in China, this one is the 33rd largest by planned enrollment of the 72 interventional ones that give a count, is one of 7 that started in 2026, is one of 10 in phase 1, reaches primary completion later than 39 of the 42 other live ones, and was the 79th registered.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
Browse Graft vs Host Disease studies →38 of the 81 studies in Graft vs Host Disease with a site in China are open now. Recruiting first, the newest first:
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 8–18
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Sites in China
Ages 18–75
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 3–17
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.
This study: 14 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 26 · Phase 3 14 · Phase 4 8
First in 2003; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Median enrollment 53 across the 72 interventional studies, 50 across the 9 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 81 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 571 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 2 studies filed under Graft vs Host Disease — fewer than ten, so there is no comparison to draw.
12 of the studies in Graft vs Host Disease with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07047456Phase 3Anhui Provincial HospitalEffect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies Post UCBT | 2026-12-31 |
| NCT06677255Wuhan Optics Valley Vcanbiopharma Co., Ltd.A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment | 2026-12 |
| NCT04660487The First Affiliated Hospital of Soochow UniversityRelationship Between "FODMAPs" and "GVHD" | 2026-12-01 |
| NCT07350057Shanghai Jiao Tong University School of MedicineA Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children | 2027-01-31 |
| NCT07725263Haikou Affiliated Hospital of Central South University Xiangya School of MedicineLow-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children | 2027-02-28 |
Add all 12 to your calendar (.ics) → With an account.
Among the 81 studies in Graft vs Host Disease with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 injection · Drug: Methylprednisolone
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
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.
28-day overall response rate (ORR) of acute gastrointestinal GVHD
28-day gastrointestinal aGVHD ORR: CR+PR rate at Day 28 per MAGIC criteria.
Time frame: 28-day
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.
Time frame: 1-year post-randomization
Cumulative incidence of relapse（CIR）
Competing-risk endpoint for hematological relapse from randomization, with non-relapse death as competing risk.
Time frame: 1-year post-randomization
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for May 2029, 36 months after the start.
Of 39 non-industry phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's planned 36 months is below that.
Counting every sponsor, half of 49 studies reached it within 47 months; a quarter within 24 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Chinese PLA General Hospital →