A Phase 1/2 interventional study of Specific T- Lymphocytes in Adenovirus, Cytomegalovirus Infections and Epstein-Barr Virus Infections, sponsored by Paul Szabolcs. Enrolling by invitation at 1 site in United States. Open to participants aged 1 Month to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Paul Szabolcs · Phase 1/2, Interventional, and Treatment
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.
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:
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:
These subjects may receive additional cellular infusions as clinically indicated:
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.
136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.
This study's planned enrollment of 25 is below the median of 30 across 109 interventional studies indexed under Adenoviridae Infections.
Browse Adenoviridae Infections studies →Paul Szabolcs is the lead sponsor of 9 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Adenovirus Infection or Disease:
B.CMV Infection or Disease:
C. EBV Infection or Disease:
i. There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation.
ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood of PTLD patients.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Specific T- Lymphocytes
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Time frame: 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
Time frame: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Time frame: 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
Time frame: 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
Time frame: 1 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Time frame: 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
Time frame: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Time frame: 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
Time frame: 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
Time frame: 3 month from first cellular infusion
Clinical response to treatment of viral infection
Rate of Elimination or reduction of oxygen dependence identified at baseline
Time frame: 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
Time frame: 6 months from first cellular infusion
Clinical response to treatment of viral infection
Rate of Resolution of fever, attributable to viral disease
Time frame: 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
Time frame: 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
Time frame: 6 months from first cellular infusion
1-year overall survival from first cellular infusion (continuous)
Number of deaths that occurred from treatment
Time frame: First cellular infusion to 1 year post first cellular infusion
Incidence of Graft rejection
How frequent, if any, graft rejection occurs
Time frame: 3 months after last cellular infusion
Incidence of Graft rejection
How frequent, if any, graft rejection occurs
Time frame: 6 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
How long, if any
Time frame: 3 months after last cellular infusion
Incidence of Mechanical ventilation exceeding 48 hours
How long, if any
Time frame: 6 months after last cellular infusion
Usage of concomitant antiviral agents
The introduction of concomitant antiviral medication post infusion, if any
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
The pace of systemic immune reconstitution, measured by the increased number of CD4+ T lymphocytes.
Time frame: 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.
Time frame: 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
Time frame: 6 months from first cellular infusion
Plan to share: No
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Paul Szabolcs