NCT06321198RecruitingNot Applicable
A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease
Anhui Provincial Hospital1 site in 1 country12 target enrollmentStarted: February 10, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Study Overview
Brief Summary
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Detailed Description
A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.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;
Exclusion Criteria
- •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;
- •Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;
- •Not suitable for this clinical trial for other reasons.
Arms & Interventions
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;
Intervention: iMSC (Biological)
Outcomes
Primary Outcomes
Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Time Frame: From the date of initial infusion to 180 days after initial infusion
Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0
Dose-Limiting Toxicity(DLT)
Time Frame: 4 weeks after initial infusion
Number of Dose-limiting toxicity in 28 days after injection
Secondary Outcomes
- Overall Survival(OS)(100 days after initial infusion)
- Objective Response Rate(ORR)(28 days after initial infusion)
Investigators
Xiaoyu Zhu
Chief physician
Anhui Provincial Hospital
Study Sites (1)
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