A Phase 1 interventional study of CMV Specific T Cell donor lymphocyte infusion in Cytomegalovirus Infections, sponsored by Nelson Chao. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Nelson Chao · Phase 1, Interventional, and Prevention
Human cytomegalovirus (CMV) is a benign infectious agent in the normal host, but in immunocompromised individuals, such as recipients of stem cell transplants, this virus is a major cause of morbidity and mortality. While pharmacologic agents exist to treat CMV disease, these medications have numerous side effects, the most serious of which is myelosuppression. The frequency of neutropenia ranges from 41% to 58% in stem cell transplant (SCT) patients treated with ganciclovir. Withdrawal of anti-CMV therapy due to these complications may result in recurrent disease. The restoration of cellular immunity to CMV is necessary in order to prevent viral reactivation, and the generation of cytotoxic T cells against CMV early antigens is perhaps the most important part of the host immune response to CMV. At day 40 post-transplant, for example, at least 65% of SCT patients are deficient in CD8+ T-cell responses to CMV. Previous studies have demonstrated a direct correlation between CMV infection in these patients and cytotoxic T lymphocyte (CTL) function, with patients who have defects in cellular immunity being at high risk for invasive CMV disease. The median time post-transplant for the development of CMV disease is 50 to 60 days, and CMV re-activation occurs in 70 to 80% of CMV sero-positive SCT recipients. Without anti-viral therapy as many as 50% of these patients will develop CMV disease.
This protocol will evaluate the safety of CMV specific T cell infusion following nonmyeloablative stem cell transplantation from 3-6/6 HLA matched donors as well as evaluate the efficacy of antigen specific T cell infusions in preventing CMV activation.
359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 233 interventional studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →Nelson Chao is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Donor Inclusion/Exclusion Criteria
There will be an equal number of subjects (10) receiving transplants from 3-5/6 Human Leukocyte Antigen (HLA) Matched Donors as those receiving transplants from 6/6 HLA Matched Donors for a total of 20 subjects on study.
Biological: CMV Specific T Cell donor lymphocyte infusion
There will be an equal number of subjects (10) receiving transplants from 3-5/6 HLA Matched Donors as those receiving transplants from 6/6 HLA Matched Donors for a total of 20 subjects on study.
Biological: CMV Specific T Cell donor lymphocyte infusion
Donor Lymphocyte Infusion (DLI)
Also known as: Miltenyi Biotec
Safety of CMV Specific T cell infusion following Stem Cell Transplant
Donor Lymphocyte Infusion (DLI) of CMV Specific T cell clones following nonmyeloablative allogeneic stem cell transplant for the prevention of CMV
Time frame: 2 years
Efficacy of CMV-specific T cell infusion in terms of response, progression free survival, and overall survival
The efficacy and its effect on survivability will be assessed.
Time frame: 2 years
Evaluate the recovery of immune function post engraftment with this regimen.
Blood samples will be collected for immune reconstitution studies, including assessing CMV specific responses, just prior to each cell infusion, and 3,6, 12 months post last infusion.
Time frame: 2 years
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Nelson Chao