CMV-CTL for the Treatment of CMV Infection After HSCT

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborator: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Treatments: Foscarnet; Ganciclovir; Ganciclovir triphosphate

Criteria

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.