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

Plain Language Summary

Simplified for easier understanding

This study is testing a new approach to prevent a dangerous virus called cytomegalovirus (CMV) in patients who have received a stem cell (bone marrow) transplant. CMV can cause serious illness after a transplant when the immune system is very weak. The study uses two types of immune cells taken from the transplant donor — T lymphocytes and dendritic cells — and gives them back to the patient as a kind of vaccine to help rebuild the immune system's ability to fight CMV. You may be eligible if: - You are a transplant recipient receiving a blood stem cell (bone marrow) transplant - Both you and your donor are HLA-A2 positive (a specific immune system marker) - Your donor has been previously exposed to CMV (CMV seropositive) - Your transplant is a full or one-antigen-mismatched match from your donor You may NOT be eligible if: - Your donor is HLA-A2 negative - Your donor has never been exposed to CMV (CMV seronegative) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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