Trial Outcomes & Findings for Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV (NCT NCT04364178)

NCT ID: NCT04364178

Last Updated: 2026-05-27

Results Overview

Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)

Results posted on

2026-05-27

Participant Flow

Participants were enrolled at UPMC (University of Pittsburgh Medical Center). Participants were able to receive up to 5 infusions. If a subject showed a partial response, defined as a decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms, or no response, they were eligible to receive up to 4 additional cellular infusions from the same donor, at a minimum of 14-day intervals.

Participant milestones

Participant milestones
Measure
Viral Specific T-Lymphocytes
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Overall Study
STARTED
8
Overall Study
Received Treatment
5
Overall Study
Received Only 1 Infusion
4
Overall Study
Received 2 Infusions
1
Overall Study
Number of Subjects That Received CMV VSTs
2
Overall Study
Number of Subjects That Received Adenovirus VSTs
3
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Viral Specific T-Lymphocytes
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Overall Study
Screen Failed
3

Baseline Characteristics

Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Viral Specific T-Lymphocytes
n=8 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Age, Categorical
<=18 years
7 Participants
n=51 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=51 Participants
Age, Categorical
>=65 years
0 Participants
n=51 Participants
Age, Continuous
8 years
n=51 Participants
Sex: Female, Male
Female
1 Participants
n=51 Participants
Sex: Female, Male
Male
7 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=51 Participants
Race (NIH/OMB)
Asian
0 Participants
n=51 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=51 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=51 Participants
Race (NIH/OMB)
White
7 Participants
n=51 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=51 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
Region of Enrollment
United States
8 Participants
n=51 Participants

PRIMARY outcome

Timeframe: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)

Population: 3 of the total enrolled participants did not receive treatment after screening

Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Patients With Grade III-IV Acute Graft Versus Host Disease
0 Participants

PRIMARY outcome

Timeframe: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)

Population: 3 of the total enrolled participants did not receive treatment after screening

Cumulative number of patients with CTCAE Grade 4/5 Adverse events which occurred after infusion

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion
0 Participants

SECONDARY outcome

Timeframe: First cellular infusion to 6 months post first cellular infusion (last infusion occurred up to 38 days post day 0)

Population: 3 of the total enrolled participants did not receive treatment after screening

Cumulative number of patients surviving at 6 months

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Patients Who Reached 6 Month Survival
4 Participants

SECONDARY outcome

Timeframe: 1 year after first infusion

Population: 3 of the total enrolled participants did not receive treatment after screening

Cumulative number of patients who were treated and surviving one year later

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Patients Who Achieved One Year Survival
4 Participants

SECONDARY outcome

Timeframe: 1, 3, and 6 months after first infusion

Population: 3 of the total enrolled participants did not receive treatment after screening

Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Patients Who Achieved Viral Response (Complete Response) to Treatment
1 month after first infusion
3 Participants
Patients Who Achieved Viral Response (Complete Response) to Treatment
3 months after first infusion
4 Participants
Patients Who Achieved Viral Response (Complete Response) to Treatment
6 months after first infusion
4 Participants

SECONDARY outcome

Timeframe: Baseline through 6 months after last infusion

Population: 3 of the total enrolled participants did not receive treatment after screening

Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=4 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Days to Patient Complete Response to Viral Specific Infusion
22.5 days
Interval 8.0 to 89.0

SECONDARY outcome

Timeframe: Day 0 through 6 months after last infusion

Population: 3 of the total enrolled participants did not receive treatment after screening; One of the patients treated did not achieve a compete response and did not wean off antiviral treatment

The number of days after the VST infusion that the antiviral agent used for treatment of the specific virus was stopped.

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=4 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Days Post-VST Infusion Upon Which Viral Specific Antimicrobial Treatment Was Discontinued.
23 days
Interval 8.0 to 36.0

SECONDARY outcome

Timeframe: Baseline through 6 months after last infusion

Population: 3 of the total enrolled participants did not receive treatment after screening

Immune reconstitution is defined as CD4 lymphocyte count greater than 50/microliter

Outcome measures

Outcome measures
Measure
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Number of Days Post VST Infusion That Patients Achieved T Cell Immune Reconstitution
81 days
Interval 28.0 to 109.0

Adverse Events

Viral Specific T-Lymphocytes

Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Viral Specific T-Lymphocytes
n=5 participants at risk
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
20.0%
1/5 • Up to 1 year
Infections and infestations
Disseminated CMV
20.0%
1/5 • Up to 1 year

Other adverse events

Other adverse events
Measure
Viral Specific T-Lymphocytes
n=5 participants at risk
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system. Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused. Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Metabolism and nutrition disorders
Hypoalbuminemia
20.0%
1/5 • Up to 1 year
Metabolism and nutrition disorders
Hypocalcemia
20.0%
1/5 • Up to 1 year
Investigations
Lymphocyte count decreased
40.0%
2/5 • Up to 1 year
Renal and urinary disorders
Meatal stenosis with ballooning
20.0%
1/5 • Up to 1 year
Gastrointestinal disorders
Nausea
20.0%
1/5 • Up to 1 year
Investigations
Neutrophil count decreased
20.0%
1/5 • Up to 1 year
Skin and subcutaneous tissue disorders
Rash acneiform
20.0%
1/5 • Up to 1 year
Infections and infestations
Viremia
20.0%
1/5 • Up to 1 year
Infections and infestations
Urinary Tract Infection
20.0%
1/5 • Up to 1 year
Infections and infestations
Adenovirus - blood
40.0%
2/5 • Up to 1 year
Infections and infestations
Adenovirus - stool
20.0%
1/5 • Up to 1 year
Investigations
Alanine Aminotransferase increased
20.0%
1/5 • Up to 1 year
Blood and lymphatic system disorders
Anemia
20.0%
1/5 • Up to 1 year
Infections and infestations
Aspartate aminotransferase increased
20.0%
1/5 • Up to 1 year
Investigations
CD4 lymphocytes decreased
20.0%
1/5 • Up to 1 year
Renal and urinary disorders
Chronic Kidney Disease
20.0%
1/5 • Up to 1 year
Respiratory, thoracic and mediastinal disorders
Cough
20.0%
1/5 • Up to 1 year
Gastrointestinal disorders
Diarrhea
20.0%
1/5 • Up to 1 year
Investigations
Gamma glutamyl transferase increased
20.0%
1/5 • Up to 1 year
Gastrointestinal disorders
Gastroparesis
20.0%
1/5 • Up to 1 year
Vascular disorders
Hypertension
40.0%
2/5 • Up to 1 year

Additional Information

Jessie Alexander, MD

Stanford University

Phone: 650-725-9250

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place