Status:
WITHDRAWN
Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A)
Lead Sponsor:
AlloVir
Collaborating Sponsors:
Baylor College of Medicine
The Methodist Hospital Research Institute
Conditions:
Adenovirus Infection
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the bod...
Detailed Description
To make AdV-specific T cells (Viralym-A cells), small pieces of protein called peptides that come from AdV were mixed with blood cells from healthy donors. These peptides train a kind of white blood c...
Eligibility Criteria
Inclusion
- 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 adenovirus 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 cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function.
- i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by polymerase chain reaction (PCR) or culture from ONE site, such as stool or blood or urine or nasopharynx.
- ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, Direct fluorescent assay (DFA) or culture from two or more sites such as stool or blood or urine or nasopharynx.
- 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 any other quantitative assay) after 7 days of antiviral therapy.
- Patients with multiple viral infections including AdV are eligible if their AdV infection is persistent despite standard therapy as defined above. Patients with multiple infections with one or more reactivation and one or more controlled infection are eligible to enroll.
- Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day prednisone (or equivalent).
- Received transplant care locally and will remain in the Houston area for at least 6 weeks post Viralym-A infusion.
- Hemoglobin (Hgb) \> 8.0 (may be transfused).
- Available Viralym-A 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
- Patients receiving Anti-thymocyte globulin (ATG), Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of treatment with Viralym-A.
- 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-A infusion.
- Requirement for FiO2 \> 0.5 to maintain arterial oxygen saturation \> 90%
- Endotracheal intubation and mechanical ventilation at any FiO2
- Hemodynamic instability requiring continuous infusions of inotropes or vasopressors
- Patients who have received other investigational drugs within 28 days of Viralym-A infusion.
- Patients with active acute graft versus host disease (GVHD) grades II-IV.
- Active and uncontrolled relapse of malignancy.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02276820
Start Date
December 7 2017
End Date
December 1 2019
Last Update
July 23 2018
Active Locations (2)
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1
Texas Childrens Hospital
Houston, Texas, United States, 77030
2
The Methodist Hospital system
Houston, Texas, United States, 77030