AdenovirusPhase 1/2Gamma CaptureNCT06027879
Anti-viral T-cell Therapy by Gamma Capture
A Phase 1/2 study testing Specific T- Lymphocytes in people with Adenovirus and Cytomegalovirus Infections, run by Paul Szabolcs at 1 site in United States.
Trial summary
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic… Read more about this study
- Who is it for?
- Ages 1 month to 65 years
- Conditions the study is for
- Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus Infections
- What is being tested?
- Specific T- Lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 1 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For pediatric subject who are developmentally able, assent or affirmation will be obtained, if feasible.
- Male or female, 1 month through 75 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood stem cells, single or double cord blood), OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, or multivisceral), OR diagnosis of primary immunodeficiency OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized. All females of childbearing potential and lactation must agree to use an FDA approved method of birth control for the duration of their participation.
- Clinical status, at the time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
- Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy.
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- Adenovirus Infection or Disease:
- Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis, hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus by biopsy specimen from affected site(s) (by culture or histology), or the detection of adenovirus by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents) OR
- Refractory adenoviremia: defined as DNAemia >5000 copies/mL or <1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents) OR
- Intolerance of or contraindication to antiviral medications.
- B.CMV Infection or Disease:
- Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagic cystitis, and/or gastroenteritis) defined as the demonstration of CMV by biopsy specimen from affected site(s) (by culture or histology) or the detection of CMV by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents) OR
- Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥2,000 IU/mL or <1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents) OR
- Intolerance of or contraindication to antiviral medications.
- EBV Infection or Disease:
- Biopsy proven lymphoma or posttransplant lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR, OR
- Clinical or imaging findings consistent with EBV lymphoma and associated elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk, OR
- Failure of antiviral therapy, as determined by one of the two bullets below after three weeks of anti-CD20 targeted therapy such as Rituximab.
- There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation.
- There was a rise or a fall of less than 50% in EBV viral load in peripheral blood of PTLD patients.
Who cannot join
- Received Antithymocyte Globulin (ATG) or Alemtuzumab within 28 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by <10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).
- Active acute GVHD grades II-IV.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 14 days of viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 14 days of the viral-specific T cell infusion will not be excluded.
- Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).
- Received an investigational product in the preceding 2 weeks (prior to infusion) that may impact Viral Specific T-cells (VST) survival.
- Females of child bearing potential must not be lactating.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Anti-viral T-cell Therapy by Gamma Capture for High-risk Patients With Acquired or Inherited Immune Defects
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic Cell transplant (HCT) or solid organ transplant (SOT) or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. This trial will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Read the detailed description
Enrollment for existing UPMC patients.
Ideally, subjects will receive up to ≤1 x 105 (100,000) viable CD3 cells/kg however actual cell dose of infusion will be based upon available cells and subject's clinical picture. Historically, subjects have received all available cells after the gamma capture procedure.
Two-weeks post initial cellular infusion, subject may be eligible to receive additional cellular infusions. If so, either the same or an alternative donor may be considered however, a subject will not receive more than 3 infusions from one donor or exceed 6 infusions in total from all donors. Infusions will be a minimum of 14-days apart. Subjects will not receive additional infusions if they exhibit Graft Versus Host Disease (GvHD) or Cytokine Release Syndrome (CRS) Grade II or higher, according to CTCAE v5.
If a subject is to receive a second infusion, eligibility and baseline data collection will not be repeated for the recipient or original donor, unless necessary per institutional guidelines. Should an alternative donor be selected for an infusion, eligibility of the new donor will need confirmed. Pregnant donors may be considered if medically suitable.
Two weeks post-initial cellular infusion, the following criteria will be assessed to determine if additional infusions are necessary:
- Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. These subjects are not eligible to receive an additional cellular infusion.
- Partial response: Decrease in viral load of at least 50% from baseline or significant improvement of clinical signs. The clinical response is further defined as meeting one or more of the following criteria and no worsening in any of the others:
- Absence of fever, if fever is present at baseline
- No need for pressors, if on pressors at baseline
- No need for oxygen and/or mechanical ventilation, if needed at baseline
- Decrease in stool output, if is diarrhea present at baseline
These subjects may receive additional cellular infusions as clinically indicated:
- Stable disease: Changes insufficient to qualify as partial response or progression. These subjects are eligible to receive additional cellular infusions.
- Progression: Increase in viral load of at least 50% from baseline or dissemination to other sites of disease. These subjects are eligible to receive additional cellular infusions.
Subjects are followed for six months post initial viral-specific T cell infusion. If a subject receives additional infusions, GVHD and adverse events only will be followed for a minimum of three months from last infusion, even if extending beyond the six-month follow-up from the first infusion. Data may be abstracted from subjects' medical charts for an additional 1 year after most recent viral-specific T cell infusion.
- Being tested
- Specific T- Lymphocytes
- Medical subject headings
- Adenoviridae Infections, Cytomegalovirus Infections, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific T- LymphocytesBiological
Peripheral blood mononuclear cells will be collected from the donor and loaded onto 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.
| Study group | Role | What they receive |
|---|---|---|
| Viral Specific T-Lymphocytes | Experimental | 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. Receives: Biological: Specific T- Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade III-IV Acute GvHD
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Measured: Day 0
Grade III-IV Acute GvHD
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Measured: 1 month from first cellular infusion
Grade III-IV Acute GvHD
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Measured: 3 month from first cellular infusion
Grade III-IV Acute GvHD
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Measured: 6 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Measured: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Measured: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Measured: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Measured: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
Measured: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Measured: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Measured: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Measured: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Measured: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
Measured: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Measured: 6 months from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Measured: 6 months from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Measured: 6 months from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Measured: 6 months from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
Measured: 6 months from first cellular infusion
Secondary outcomes (9)
1-year overall survival from first cellular infusion (continuous)
Number of deaths that occurred from treatment
Measured: First cellular infusion to 1 year post first cellular infusion
Incidence of Graft rejection
How frequent, if any, graft rejection occurs
Measured: 3 months after last cellular infusion
Incidence of Graft rejection
How frequent, if any, graft rejection occurs
Measured: 6 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
How long, if any
Measured: 3 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
How long, if any
Measured: 6 months after last cellular infusion
Usage of concomitant antiviral agents
The introduction of concomitant antiviral medication post infusion, if any
Measured: First cellular infusion to 1 year post first cellular infusion
Immune reconstitution with focus on adaptive T cell immunity and viral-specific responses
The pace of systemic immune reconstitution, measured by the increased number of CD4+ T lymphocytes.
Measured: 1 month following first cellular infusion
Immune reconstitution with focus on adaptive T cell immunity and viral-specific responses
The pace of systemic immune reconstitution, measured by the increased number of CD4+ T lymphocytes.
Measured: 3 months following first cellular infusion
Incidence of severe or extensive chronic GVHD
The number of patients who develop chronic graft versus host disease (GVHD) post first infusion based on Clinical Chronic GvHD Assessment
Measured: 6 months from first cellular infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start8 Jan 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paul Szabolcs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Szabolcs, University of Pittsburgh
- Investigators
- Paul Szabolcs, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027879
- Sponsor's protocol ID
- STUDY23030062
- Acronym
- Gamma Capture
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-viral T-cell Therapy by Gamma Capture for High-risk Patients With Acquired or Inherited Immune Defects
- ClinicalTrials.gov ID
- NCT06027879
- Acronym / sponsor ID
- Gamma Capture / STUDY23030062
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Paul SzabolcsUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic Cell transplant (HCT) or solid organ transplant (SOT) or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. This trial will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Detailed description
Enrollment for existing UPMC patients.
Ideally, subjects will receive up to ≤1 x 105 (100,000) viable CD3 cells/kg however actual cell dose of infusion will be based upon available cells and subject's clinical picture. Historically, subjects have received all available cells after the gamma capture procedure.
Two-weeks post initial cellular infusion, subject may be eligible to receive additional cellular infusions. If so, either the same or an alternative donor may be considered however, a subject will not receive more than 3 infusions from one donor or exceed 6 infusions in total from all donors. Infusions will be a minimum of 14-days apart. Subjects will not receive additional infusions if they exhibit Graft Versus Host Disease (GvHD) or Cytokine Release Syndrome (CRS) Grade II or higher, according to CTCAE v5.
If a subject is to receive a second infusion, eligibility and baseline data collection will not be repeated for the recipient or original donor, unless necessary per institutional guidelines. Should an alternative donor be selected for an infusion, eligibility of the new donor will need confirmed. Pregnant donors may be considered if medically suitable.
Two weeks post-initial cellular infusion, the following criteria will be assessed to determine if additional infusions are necessary:
- Complete response: Return to normal range as defined by specific assay used and clinical signs and symptoms. These subjects are not eligible to receive an additional cellular infusion.
- Partial response: Decrease in viral load of at least 50% from baseline or significant improvement of clinical signs. The clinical response is further defined as meeting one or more of the following criteria and no worsening in any of the others:
- Absence of fever, if fever is present at baseline
- No need for pressors, if on pressors at baseline
- No need for oxygen and/or mechanical ventilation, if needed at baseline
- Decrease in stool output, if is diarrhea present at baseline
These subjects may receive additional cellular infusions as clinically indicated:
- Stable disease: Changes insufficient to qualify as partial response or progression. These subjects are eligible to receive additional cellular infusions.
- Progression: Increase in viral load of at least 50% from baseline or dissemination to other sites of disease. These subjects are eligible to receive additional cellular infusions.
Subjects are followed for six months post initial viral-specific T cell infusion. If a subject receives additional infusions, GVHD and adverse events only will be followed for a minimum of three months from last infusion, even if extending beyond the six-month follow-up from the first infusion. Data may be abstracted from subjects' medical charts for an additional 1 year after most recent viral-specific T cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viral Specific T-Lymphocytes | Experimental | Biological: Specific T- LymphocytesViral 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. |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For pediatric subject who are developmentally able, assent or affirmation will be obtained, if feasible.
- Male or female, 1 month through 75 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood stem cells, single or double cord blood), OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, or multivisceral), OR diagnosis of primary immunodeficiency OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized. All females of childbearing potential and lactation must agree to use an FDA approved method of birth control for the duration of their participation.
- Clinical status, at the time of consent, amendable to tapering of steroids to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
Key exclusion criteria (7 listed)
- Received Antithymocyte Globulin (ATG) or Alemtuzumab within 28 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by <10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).
- Active acute GVHD grades II-IV.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 14 days of viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 14 days of the viral-specific T cell infusion will not be excluded.
- Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).
- Received an investigational product in the preceding 2 weeks (prior to infusion) that may impact Viral Specific T-cells (VST) survival.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific T- LymphocytesPeripheral blood mononuclear cells will be collected from the donor and loaded onto 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. | Biological | Viral Specific T-Lymphocytes |
Primary outcome
Grade III-IV Acute GvHD
Time frame: Day 0
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Grade III-IV Acute GvHD
Time frame: 1 month from first cellular infusion
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Grade III-IV Acute GvHD
Time frame: 3 month from first cellular infusion
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Grade III-IV Acute GvHD
Time frame: 6 month from first cellular infusion
The number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Clinical response to treatment of viral infection
Time frame: 1 month from first cellular infusion
Rate of Elimination or reduction of oxygen dependence identified at baseline
Clinical response to treatment of viral infection
Time frame: 1 month from first cellular infusion
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Clinical response to treatment of viral infection
Time frame: 1 month from first cellular infusion
Rate of Resolution of fever, attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 1 month from first cellular infusion
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 1 month from first cellular infusion
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
Clinical response to treatment of viral infection
Time frame: 3 month from first cellular infusion
Rate of Elimination or reduction of oxygen dependence identified at baseline
Clinical response to treatment of viral infection
Time frame: 3 month from first cellular infusion
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Clinical response to treatment of viral infection
Time frame: 3 month from first cellular infusion
Rate of Resolution of fever, attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 3 month from first cellular infusion
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 3 month from first cellular infusion
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
Clinical response to treatment of viral infection
Time frame: 6 months from first cellular infusion
Rate of Elimination or reduction of oxygen dependence identified at baseline
Clinical response to treatment of viral infection
Time frame: 6 months from first cellular infusion
Rate of Resolution of diarrhea attributable to the viral disease, less than 4 stools daily
Clinical response to treatment of viral infection
Time frame: 6 months from first cellular infusion
Rate of Resolution of fever, attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 6 months from first cellular infusion
Rate of Resolution or improvement of radiographic findings attributable to viral disease
Clinical response to treatment of viral infection
Time frame: 6 months from first cellular infusion
Rate of Resolution or improvement of lymphadenopathy attributable to EBV, and ophthalmic findings attributable to CMV retinitis
9 secondary outcomes
1-year overall survival from first cellular infusion (continuous)
Time frame: First cellular infusion to 1 year post first cellular infusion
Incidence of Graft rejection
Time frame: 3 months after last cellular infusion
Incidence of Graft rejection
Time frame: 6 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
Time frame: 3 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
Time frame: 6 months after last cellular infusion
Usage of concomitant antiviral agents
Time frame: First cellular infusion to 1 year post first cellular infusion
Immune reconstitution with focus on adaptive T cell immunity and viral-specific responses
Time frame: 1 month following first cellular infusion
Immune reconstitution with focus on adaptive T cell immunity and viral-specific responses
Time frame: 3 months following first cellular infusion
Incidence of severe or extensive chronic GVHD
Time frame: 6 months from first cellular infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Szabolcs, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Specific T- Lymphocytes in people with Adenovirus and Cytomegalovirus Infections, run by Paul Szabolcs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade III-IV Acute GvHD (time frame: Day 0). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.