None listed
Conditions
Brief 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.
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.
Sponsors
Queensland Institute of Medical Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1) HSCT/SOT recipients who were transplanted by, and/or are currently under the care of, a haematologist or physician at the appropriate clinical facility. 2). CMV infection that falls into one of the following categories: (a) Recurrent CMV reactivation (as defined by PCR) or disease (as defined by histology) following successful initial therapy, or (b) Persistent CMV disease (no response to 2 weeks of salvage foscarnet or other second line antiviral agent), or (c) Persistent CMV replication (more than 6 weeks by PCR) despite appropriate antiviral therapy, or (d) Any CMV reactivation or disease where anti-viral therapy is contraindicated on the basis of intolerance or end organ limitation (e.g. renal impairment, marrow dysfunction). 3) Absence of uncontrolled intercurrent infection 4) Patient able to provide informed consent 5) Age 18 to 75
Exclusion criteria
1 Uncontrolled intercurrent infection 2 Eastern Cooperative Oncology Group (ECOG)status > 3 (Karnofsky performance score < 30: disabled, no self-care. Totally bedridden, or confined to chair) 3 Markers of active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) infection (presence of Hepatitis B surface Antigen (HBsAg), Hepatitis C (HepC) antibody, or HIV antibodies) 4 Uncontrolled Graft versus Host disease (GVHD) 5 Steroid doses > 1mg/kg of prednisone, or equivalent
Outcome results
None listed