CompletedPhase 1ACTRN12609000531213

T-cell Therapy for CMV (Cytomegalovirus) Disease

Adoptive immunotherapy for the treatment of cytomegalovirus (CMV) reactivation and disease after transplantation.


Sponsor

Queensland Institute of Medical Research

Enrollment

30 participants

Start Date

May 21, 2010

Study Type

Interventional

Conditions

Summary

Since the inception of human organ transplantation, HCMV remains single most-important cause of infectious morbidity and mortality in immunocompromised transplant patients. This project is designed to develop immunotherapeutic strategies based on adoptive transfer of virus- specific killer T cells for the treatment of HCMV infection in transplant patients. Who is it for? You can join this study if you have had an allogeneic haematopoietic stem cell transplant or a renal transplant at the Royal Brisbane Hospital and have a CMV infection. Trial details Blood will be collected from your stem cell donor (for SCT patients) or yourself and the CMV killer T cells grown in the laboratory (this takes about 3 weeks.) The cells are then tested for sterility and specificity. Once the cells pass these checks they will be infused into yourself: 4 doses at 2 weekly intervals and then a further 2 doses at 4 weekly intervals provided sufficient cells are produced. The effects of the treatment will be studied by monitoring your signs and symptoms and by blood tests. This will be done at the time of each treatment and then monthly for up to a year from the first treatment. Your total length of involvement will be no longer than 18 months.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a treatment using specially prepared immune cells (T-cells) to fight cytomegalovirus (CMV) infection in patients who have received an organ or bone marrow transplant and whose infection has not responded well to standard antiviral medications.

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

Allogeneic or autologous ex vivo expanded human CMV-specific T cells will be administered by intravenous infusion. Up to six doses will be given at weeks 0, 2, 4, 6, 10, and 14.

Allogeneic or autologous ex vivo expanded human CMV-specific T cells will be administered by intravenous infusion. Up to six doses will be given at weeks 0, 2, 4, 6, 10, and 14.


Locations(1)

Australia

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ACTRN12609000531213