Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
Conditions
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
Interventions
BIOLOGICALiMSC
Subjects will receive 4 or more times of iMSC injection
Sponsors
Anhui Provincial Hospital
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 70 Years
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
1. Accepted systemic or local treatment of mesenchymal stem cells; 2. Have severe allergy to blood products or have allergy history of heterologous protein; 3. Expected survival period within 3 months; 4. 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); 5. Have severe hepatic veno-occlusive disease(HVOD); 6. Have severe lung disease like severe lung infection; 7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure; 8. Proved having resistant hypertension within 6 months before enrollment; 9. Have active thrombus; 10. Have untreated or uncertain active solid tumors within 5 years; 11. 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; 12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive; 13. Have active hepatitis B or hepatitis C; 14. Have gastrointestinal symptoms which not caused by GVHD 15. 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; 16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening; 17. Not suitable for this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity(DLT) | 4 weeks after initial infusion | Number of Dose-limiting toxicity in 28 days after injection |
| Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | 28 days after initial infusion | Percentage of participants achieved Complete Response(CR) or Partial Response(PR) |
| Overall Survival(OS) | 100 days after initial infusion | The time from initial infusion to death |
Countries
China
Contacts
CONTACTXiaoyu Zhu, phd
PRINCIPAL_INVESTIGATORXiaoyu Zhu, PH.D
Anhui Provincial Hospital
Outcome results
None listed