RecruitingPhase 1ACTRN12608000458336

A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred cytomegalovirus -specific cytotoxic T lymphocytes after allogeneic stem cell transplantation

A phase 1 clinical trial of peptide-pulsed monocyte-derived dendritic cell vaccination to expand adoptively transferred CMV-specific cytotoxic T lymphocytes after allogeneic stem cell transplantation


Sponsor

Western Sydney Local Health District

Enrollment

18 participants

Start Date

Aug 7, 2012

Study Type

Interventional

Conditions

Summary

A preliminary study of the use of immune cells from transplant donors to prevent cytomegalovirus infection in recipients of blood stem cell transplants. The study hypothesis is that stimulation of infused CMV specific lymphocytes by CMV peptide pulsed DC given as a vaccine will enhance immune reconstitution. The study will use two different sorts of immune cells (called T lymphocytes and dendritic cells). These cells will be prepared in the laboratory and given back to patients after transplant to try to prevent diseases caused by the CMV virus.


Eligibility

Sex: Both males and females

Inclusion Criteria4

  • Recipient and donor pairs with haemopoietic stem cell transplant
  • Human Leukocyte Antigen (HLA)-A2 positive
  • CMV seropositive donor
  • Fully HLA-matched or one antigen mismatched allogeneic transplant

Exclusion Criteria1

  • HLA-A2 negative or CMV seronegative donor

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Interventions

Donor derived dendritic cells (DC) pulsed with cytomegalovirus (CMV) antigen and/or CMV antigen specific T cells will be injected into patients following haemopoietic stem cell transplantation. There

Donor derived dendritic cells (DC) pulsed with cytomegalovirus (CMV) antigen and/or CMV antigen specific T cells will be injected into patients following haemopoietic stem cell transplantation. There will be 3 arms: Arm 1 - CMV cytotoxic T lymphocyte (CTL) infusion only; Arm 2 - DC vaccine with CMV cytotoxic T lymohocyte infusion; Arm 3 - DC vaccination only. Doses are: CMV cytotoxic T lymphocytes - 2x10^7 per square metre of body surface area once post transplant DC vaccine - 2x10^6 per sqaure metre of body surface area twice at 7 day interval


Locations(1)

Westmead Hospital - Westmead

Australia

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ACTRN12608000458336