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CMV-CTL for the Treatment of CMV Infection After HSCT

NCT03004261 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections
  • Hematological Disease

Interventions

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.

DRUG

Ganciclovir

Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.

Sponsors & Collaborators

  • Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

    collaborator INDUSTRY

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Liping Wan, M.D.，Ph.D. · Shanghai Jiao Tong University Affiliated Shanghai General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03004261 on ClinicalTrials.gov