At a glance
ClinicalIndex Comparison Record- ✓Clinical evidence of CMV disease (e.g., interstitial pneumonia, hepatitis, retinitis, colitis) OR microbiological evidence of CMV viremia/tissue invasion by culture or CMV DNA detection
- ✓CMV infection is progressing/persistent despite ≥2 weeks of antiviral induction therapy OR CMV viremia developed while on prophylactic antiviral therapy OR unable to tolerate antivirals due to toxicity
- ✓CMV-specific T cells from transplant donor available
- ✓Stable blood pressure and circulation, not requiring pressor support
- ✕Requiring high-dose glucocorticosteroids (≥0.3 mg/kg prednisone or equivalent)
- ✕Moribund patients
- ✕Other life-threatening conditions not related to CMV that would preclude evaluation of T-cell infusion (e.g., uncontrolled bacterial sepsis, invasive fungal infection)
- ✕Pregnant patients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Primary Transplant Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating CMV-pp65 CTLs for Cytomegalovirus. Completed, enrolled 58 participants across 1 site.
Detailed Summary
The purpose of this study is to see how well transfusions of T-cells work in treating CMV. T-cells are a type of white blood cell that helps protect the body from infection. A transfusion is the process by which blood from one person is transferred to the blood of another. In this case, the T-cells are made from the blood of donors who are immune to CMV. The T-cells are then grown and taught to attack the CMV virus in a lab.
Study Details
Timeline
Interventions
Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.