Clinical trial NCT06321198: A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: A single center, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD

Eligibility criteria: 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.

Primary outcomes:
measure: Dose-Limiting Toxicity(DLT)
timeFrame: 4 weeks after initial infusion
measure: Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
timeFrame: From the date of initial infusion to 180 days after initial infusion
Secondary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: 28 days after initial infusion
measure: Overall Survival(OS)
timeFrame: 100 days after initial infusion
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
Study officials:
affiliation: Anhui Provincial Hospital
name: Xiaoyu Zhu, PH.D
role: PRINCIPAL_INVESTIGATOR
References: