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Recruiting NCT06321198

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

No phase Interventional Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iMSC.
Who it may be relevant to
Registry conditions: Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD). Basic parameters: 4 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

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

Primary outcome measures

  • Dose-Limiting Toxicity(DLT) [Time frame: 4 weeks after initial infusion]
  • 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]
Secondary outcome measures (2)
  • Objective Response Rate(ORR) [Time frame: 28 days after initial infusion]
  • Overall Survival(OS) [Time frame: 100 days after initial infusion]

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Anhui Provincial Hospital — Hefei

Identifiers

NCT: NCT06321198 · iMSC-2001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗