Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004261
Other study ID # CMV-CTL-201609
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2016
Est. completion date December 31, 2021

Study information

Verified date April 2023
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Allogeneic hematopoietic stem cell transplantation is widely used for the treatment of hematological malignancies and bone marrow failure diseases. Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Approximately half of the recipients would develop CMV infection after transplant. Present treatment recommendation for CMV infection including ganciclovir and foscarnet. However, these medications have many side effects, the most serious is myelosuppression and renal injury, moreover, many patients do not response to these medications. Considering the risk associated with persistent infection and the potential for CMV specific cytotoxic T lymphocyte (CMV-CTL) to restore immunity, we propose to study the immunologic and virologic effects of donor derived CMV-CTL given to transplant recipients, levels of CMV-CTL and CMV DNA will be measured from CTL recipients. If the patient and their donor are eligible, we will take 80 ml of fresh blood from the donor or 5 ml peripheral blood stem cell from the donor.The peripheral blood mononuclear cells will be separated from peripheral blood or peripheral blood stem cell. CMV antigen peptides will be used to induce the CMV-CTL for a period of 18~21 days. The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA levels will be monitored weekly for at least 60 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive one additional injection of CTLs. If the CMV levels in the blood continue to rise after the dose of T cells then the patient will receive treatment with Ganciclovir, Foscarnet.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years to 60 Years
Eligibility 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.

Study Design


Intervention

Biological:
donor derived cytomegalovirus specific T lymphocytes
donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.
Drug:
Foscarnet
Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.
Ganciclovir
Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.

Locations

Country Name City State
China Shanghai Jiao Tong University Affilated Shanghai General Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day response rate The percentage of patient whose serum CMV-DNA becomes negative in 30 days. from the date of CMV-CTL infusion to 30 days after the infusion
Secondary 1-year overall survival The length of patients who are alive in 1 years. from the date of transplant to 1 year after transplant
Secondary 100-day incidence of acute GVHD the incidence of acute GVHD from the date of transplant to 100 days after transplant
Secondary 1-year incidence of chronic GVHD the incidence of chronic GVHD from the date of transplant to 1 year after transplant
See also
  Status Clinical Trial Phase
Terminated NCT03950414 - A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients Phase 1
Recruiting NCT04690933 - AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Recruiting NCT02671318 - Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence Phase 4
Completed NCT01325636 - Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus Phase 1/Phase 2
Recruiting NCT00228202 - Genotyping of Cytomegalovirus From Patients in Israel N/A
Completed NCT00031421 - Neonatal CMV-Ganciclovir Follow-up Study N/A
Completed NCT00005496 - Inflammation, Infection, and Future Cardiovascular Risk N/A
Terminated NCT03262194 - Relevance of Gastric Aspirate in HCMV Detection
Completed NCT04478474 - Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients
Recruiting NCT05370976 - Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation. Phase 2
Active, not recruiting NCT02943057 - Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis Phase 4
Completed NCT02538172 - Cell-mediated Immunity for Prevention of CMV Disease N/A
Completed NCT02642822 - The Epidemiologic Study of Human Cytomegalovirus(CMV) in Female Students of Xiamen University N/A
Completed NCT02134184 - The Influence of Chronic CMV Infection on Influenza Vaccine Responses Phase 4
Completed NCT00673868 - Cytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants Phase 1
Active, not recruiting NCT05089630 - A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults Phase 1/Phase 2
Not yet recruiting NCT06058858 - Incidence and Risks Factors of CMV Reactivation in Patients Receiving of CAR-T Cells for Acute Leukemia and Lymphoma Relapse, a Cohort Study Analysis
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01986010 - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) Phase 1