RecruitingPhase 1ACTRN12605000213640

Infusion of donor-derived CMV peptide-specific CTL after allogeneic HSCT

A Phase I clinical trial of infusion of donor-derived HLA-A*0201-restricted CMV pp65 peptide-specific CTL to reconstitute CMV-specific immunity after allogeneic haematopoietic stem cell transplantation.


Sponsor

Department of Haematology, Westmead Hospital

Enrollment

12 participants

Start Date

Aug 1, 2001

Study Type

Interventional

Conditions

Summary

CMV infection or reactivation causes morbidity and mortality in patients after allogeneic HSCT. We aim to adoptively transfer donor-derived CMV-specific CTL to prevent CMV infection and reactivation in these patients.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study tests whether transferring specialised immune cells (called CMV-specific cytotoxic T lymphocytes or CTLs) from a stem cell donor to a patient who has received a stem cell transplant can prevent or treat cytomegalovirus (CMV) infection. CMV is a common virus that can cause serious illness in people with weakened immune systems after transplant. You may be eligible if: - You have received an allogeneic (donor) blood stem cell transplant - It has been more than 28 days since your transplant - Your donor is HLA-A*0201 positive and CMV positive - You had a matched sibling donor (5/6 or 6/6 match) or a 6/6 matched unrelated donor - Your graft-versus-host disease (GVHD) is less than grade II at the time of infusion - You have not recently received anti-lymphocyte therapy You may NOT be eligible if: - There are no additional specific exclusion criteria listed beyond meeting the above requirements Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Phase I study of intravenous infusion of monocyte-derived dendritic cell-primed, donor-derived, HLA-A*0201-restricted, CMV pp65 peptide-specific in vitro expanded cytotoxic T lymphocytes on or after d

Phase I study of intravenous infusion of monocyte-derived dendritic cell-primed, donor-derived, HLA-A*0201-restricted, CMV pp65 peptide-specific in vitro expanded cytotoxic T lymphocytes on or after day 28 post stem cell infusion.


Locations(1)

Australia

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ACTRN12605000213640