Recruiting

Early Phase 1

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

Sponsor:

Sumithira Vasu

Code:

NCT03665675

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Cytomegalovirus

Donor

Solid Organ Transplantation Recipient

Adenovirus

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

Interventions

Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Study Details

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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Cytomegalovirus

Donor

Solid Organ Transplantation Recipient

Adenovirus

Study ID

NCT03665675

Start date

Nov 7, 2020

Status verified date

Mar, 2026

Completion date

Dec 20, 2026

Anticipated

Primary completion date

Aug 20, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 70+

Healthy Volunteers: Accepted

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, 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 Criteria:

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (CMV-specific CTLs)

Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

experimental: Treatment (AdV-specific CTLs)

Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Interventions

Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes

Given intravenously

Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes

Given intravenously

Primary outcome measure

Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Up to 30 days post infusion ]
Feasibility defined as identifying a suitable donor within 4 weeks and meeting minimum T cell doses in the final product [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Nicole Szuminski

614-688-9796 Nicole.Szuminski@osumc.edu

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Melinda Triplet, RN, BSN

614-722-6039 Melinda.Triplet@nationwidechildrens.org

More Information

Sponsor

Sumithira Vasu

Last update posted

Apr 15, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sumithira Vasu on 2026-04-15.