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Donor Virus-Specific CTL to Treat CMV or AdV Reactivation After Transplant

This study is looking at how safe and effective two different treatments are for people who have had a stem cell or solid organ transplant and are now experiencing a return of Cytomegalovirus (CMV) or Adenovirus (AdV) infection. The treatments are called allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor CMV-specific CTLs) and allogeneic adenovirus-specific cytotoxic T lymphocytes (donor AdV-specific CTLs). These are special white blood cells from a donor that may help fight the virus. The study aims to see if these treatments cause side effects and if they can be successfully prepared and given to patients. You may be able to join if you are between 1 and 85 years old and have had a solid organ or stem cell transplant with documented CMV or AdV reactivation or disease. The study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This study is interventional and involves two groups of participants, each receiving a different treatment. It plans to enroll 20 participants.
What's involved
You would receive the study treatment intravenously. You would also have blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid samples collected.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up for up to 1 year after the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03665675

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

Recruiting
EARLY_PHASE1Ages 1–85InterventionalTreatment
Sumithira Vasu
~20 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytesAllogeneic Adenovirus-specific Cytotoxic T Lymphocytes

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0
Measured over Up to 30 days post infusion
+1 more outcome measured

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Cytomegalovirus
Donor
Solid Organ Transplantation Recipient
Adenovirus

Explore related trials

AdenovirusCytomegalovirusHematopoietic Cell TransplantationSolid Organ TransplantationAdVCytomegaloviral Infection

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Sumithira Vasu, MBBS · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

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
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

Exclusion

Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.
Receipt of \> 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg/kg/day of prednisone or steroid equivalent.
Evidence of uncontrolled infection as follows:
Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.
Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Receipt of donor lymphocyte infusion (DLI) within 28 days.
Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \> 0.5 mg/kg/day of prednisone or steroid equivalent or T-cell depleting immunosuppression.
Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.
Active and uncontrolled relapse of malignancy.

What this trial measures

  • Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0Up to 30 days post infusion

    Measured as the proportion of patients with acute (a) graft versus host disease (GvHD) grades III-IV or graft rejection/failure within 30 days of the last dose of cytotoxic T-lymphocytes (CTLs) or grades 3-5 infusion-related adverse events within 7 days of the last does of CTLs or grades 4-5 non-hematological adverse events within 30 days of the last dose of CTLs and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities. Will be calculated by dividing by all evaluable patients and the corresponding 95% confidence intervals will be calculated.

  • Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final productUp to 1 year