Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
• Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.
• • Cohort A (CMV): Must have documented CMV disease or reactivation, as by:
‣ Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR
⁃ High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR
⁃ Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
‣ • Cohort B (AdV): Must have documented AdV infection or reactivation, as by:
⁃ Symptomatic subject with any detectable viral load in blood, OR
⁃ Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and/or other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR
⁃ New, persistent, and/or worsening AdV-related symptoms, signs, and/or markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR
⁃ Asymptomatic with a viral load \> 1000 copies/ml in peripheral blood, OR
⁃ Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury
• Karnofsky (age \> 16 years) or Lansky performance score \> 70 (age \< 16)
∙ Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation
∙ Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen
∙ Written informed consent and/or signed assent line from patient, parent or guardian
∙ DONOR
∙ Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards
∙ Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)
∙ Cohort B: AdV seropositive, defined as detection of serum AdV IgG
∙ Age 18 or over
∙ Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol