Cytomegalovirus Specific Cytotoxic T Lymphocyte for the Treatment of Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

CMV-CTL-201609

Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte (CMV-CTL) given to transplant recipients CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived from donor peripheral blood mononuclear cells for a period of 18\~21 days.The patients will receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA level will be monitored weekly after transfusion.

2016-11-01

2021-12-31

2021-12-31

Completed

Early phase I

5

Inclusion Criteria: * Any allogeneic stem cell transplant recipient ≥ 14 years of age and ≤ 60 years of age * Bilirubin/ SGOT/SGPT \< 5 × upper normal limits. * Creatinine \< 2 × upper normal limits. * Ejection fraction ≥ 50%, no severe arrhythmia. * Estimated life expectancy ≥ 6 months. * Patients' CMV-DNA ≥ 1000cp/ml in treatment group and being negative in prophylactic group. Exclusion Criteria: * Patients receiving prednisone ≥ 1mg/kg/d for the treatment of acute GVHD or mild, severe chronic GVHD. * Recipient \< 14years of age * Donor is sero-positive in HBV/HCV/HIV or RPR.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2023-04-25