A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

NCT06949267 | Not Yet Recruiting Early Phase 1

• 1 other identifier: RJ-BMT-GvHD-001
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.

Conditions

Acute Graft-versus-Host Disease

Keywords

iMSC; III-IV aGVHD; allogeneic hematopoietic stem cell transplantation; prophylaxis

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of degree III-IV aGvHD

  Cumulative incidence of degree III-IV aGvHD at 100 days Within 100 days of first dose

  Within 100 days of first dose

Secondary Outcomes (3)

• Cumulative Recurrence Rate (CIR)

  Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose

• Disease-free survival (DFS)

  Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose

• Adverse Event(AE) or Serious Adverse Event(SAE)

  Day 100 after initial infusion

Study Arms (2)

Control group

ACTIVE COMPARATOR

conventional aGVHD prophylaxis

Combination Product: conventional aGVHD prophylaxis

Trial group

EXPERIMENTAL

conventional aGVHD prophylaxis + iMSC

Biological: iMSC; Combination Product: conventional aGVHD prophylaxis

Interventions

iMSC BIOLOGICAL

1× 10\^6/kg each time, twice a week

Trial group

conventional aGVHD prophylaxis COMBINATION_PRODUCT

Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin（ATG）

Control group; Trial group

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
• No gender restrictions and age between 14-70 years old；
• Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
• Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP\< 0.14 at +7d, another test was performed at +14d)；
• Estimated survival≥ 24 weeks；
• Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；
• Subjects were be treated within 5 days after enrollment；
• Informed consent and willingness to participate in the study.

You may not qualify if:

• Serious organ dysfunction such as organ failure after allogeneic HSCT;
• Received more than once HSCT (including autologous transplants);
• Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
• Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
• Primary malignant hematologic disease was not remission;
• Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;
• Those who are suffering mental or neurological illnesses, unable to express will correctly;
• Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;
• Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;
• Have participated or are participating in another clinical trial within one month prior to enrollment;
• Those who are judged by the investigator to be unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Officials

• Xiaoxia Hu, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoxia Hu, MD

CONTACT

+86 021-64370045; hu_xiaoxia@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: enrolled subjects will be 1:1 randomly assigned to experimental group or control group.The control group will receive conventional aGVHD prophylaxis and the experimental group will be receive iMSC injection plus the conventional aGVHD prophylaxis

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-03