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

Официальное название

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

Обзор

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

Подробное описание

A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD

Вмешательства

• Биопрепарат iMSC
  Subjects will receive 4 or more times of iMSC injection

Первичные конечные точки

• Dose-Limiting Toxicity(DLT) [Срок оценки: 4 weeks after initial infusion]
• Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE) [Срок оценки: From the date of initial infusion to 180 days after initial infusion]

Вторичные конечные точки (2)

• Objective Response Rate(ORR) [Срок оценки: 28 days after initial infusion]
• Overall Survival(OS) [Срок оценки: 100 days after initial infusion]

Критерии участия

Критерии включения

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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Anhui Provincial Hospital — Хэфэй

Идентификаторы

NCT: NCT06321198 · iMSC-2001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗