A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD

NCT06321198 | Recruiting

• 1 other identifier: iMSC-2001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD

Conditions

Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity(DLT)

  Number of Dose-limiting toxicity in 28 days after injection

  4 weeks after initial infusion

• Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)

  Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0

  From the date of initial infusion to 180 days after initial infusion

Secondary Outcomes (2)

• Objective Response Rate(ORR)

  28 days after initial infusion

• Overall Survival(OS)

  100 days after initial infusion

Study Arms (1)

iMSC injection

EXPERIMENTAL

Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week;

Biological: iMSC

Interventions

iMSC BIOLOGICAL

Subjects will receive 4 or more times of iMSC injection

iMSC injection

Eligibility Criteria

• Age: 4 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;

You may not qualify if:

• Accepted systemic or local treatment of mesenchymal stem cells;
• Have severe allergy to blood products or have allergy history of heterologous protein;
• Expected survival period within 3 months;
• Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\>2\*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)\>2\*upper limit of normal(ULN), International Normalized Ratio (INR)\>1.5\*upper limit of normal(ULN);
• Have severe hepatic veno-occlusive disease(HVOD);
• Have severe lung disease like severe lung infection;
• Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;
• Proved having resistant hypertension within 6 months before enrollment;
• Have active thrombus;
• Have untreated or uncertain active solid tumors within 5 years;
• Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
• Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;
• Have active hepatitis B or hepatitis C;
• Have gastrointestinal symptoms which not caused by GVHD
• Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS): collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230036, China

RECRUITING

Study Officials

• Xiaoyu Zhu, PH.D

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyu Zhu, phd

CONTACT

+86 15255456091; xiaoyuz@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: February 10, 2024
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)