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Recruiting EARLY_Phase 1 NCT03665675

Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT

Trial Parameters

Condition Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Sponsor Sumithira Vasu
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 20
Sex ALL
Min Age 1 Year
Max Age 85 Years
Start Date 2020-11-07
Completion 2026-02-20
Interventions
Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesAllogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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

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