Most Closely Human Leukocyte Antigen (HLA)-Matched CMV-specific T Lymphocytes (Viralym-C)
CMV Infections
About this trial
This is an interventional treatment trial for CMV Infections focused on measuring Viralym-C, Viral infections post HSCT, Virus-specific T cells
Eligibility Criteria
Inclusion Criteria:
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood within 24 months.
Persistent or recurrent cytomegalovirus infection or disease despite at least 7 days of standard therapy or failure of therapy as described below or if unable to tolerate standard therapy. Standard therapy is defined as antiviral therapy with ganciclovir or CMX001 (brincidofovir) as the agents of choice and foscarnet or cidofovir as second line agents.
i.Cytomegalovirus infection: defined as the presence of CMV positivity as detected by Polymerase chain reaction (PCR) or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx.
ii. Cytomegalovirus disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination.
iii. Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy.
- Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
- Hemoglobin (HgB)>8.0 (may be transfused)
- Received transplant care locally and will remain in the Houston area for at least 6 weeks post Viralym-C infusion
- Pulse oximetry of > 90% on room air
- Available Viralym-C T cell line
- Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Exclusion Criteria:
- Patients receiving (anti-thymocyte globulin) ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of treatment with Viralym-C
- Patients with other uncontrolled/progressing infections defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days of Viralym-C infusion.
- Patients who have received other investigational drugs within 28 days of Viralym-C infusion
- Patients with active acute Graft versus host disease (GVHD) grades II-IV.
- Active and uncontrolled relapse of malignancy
Sites / Locations
- Texas Childrens Hospital
- The Methodist Hospital system
Arms of the Study
Arm 1
Experimental
Viralym-C
Partially HLA-matched Viralym-C cells will be thawed and given by intravenous injection. Patients will receive 2 x 10^7 partially HLA-matched Viralym-C/m2 as a single infusion. If a patient has a partial response they are eligible to receive up to 4 additional doses at biweekly intervals. These doses would come from the original infused line if sufficient vials were available but may come from another line if there are insufficient cells in the original line.