Actively Recruiting
Viral Specific T-Lymphocytes by Cytokine Capture System to Treat Adenovirus, Cytomegalovirus, or Epstein-Barr Virus Infections After Hematopoietic Cell or Solid Organ Transplant and in Patients With Compromised Immunity
Led by Jessie L. Alexander · Updated on 2025-08-14
25
Participants Needed
3
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of partially matched viral specific T cells to treat infections caused by adenovirus, cytomegalovirus (CMV), and Epstein-Barr virus (EBV) in patients who have weakened immune systems due to prior allogeneic hematopoietic cell transplant, solid organ transplant, or other causes. This phase I/II study aims to assess whether these donor-derived T cells can help control persistent or resistant viral infections that have not responded to standard therapies. The study uses a new gamma capture technology to generate these virus-specific T cells more quickly and potentially at lower cost than patient-specific products. The treatment involves collecting peripheral blood mononuclear cells from a donor, stimulating them with viral-specific antigens, and then isolating the viral specific T cells using an interferon gamma cytokine capture system. Patients may receive up to five infusions of these cells from one or two donors, spaced at least 14 days apart, especially if they show a partial or no response to initial infusion. This cellular therapy is given intravenously, and patients are monitored closely for safety and effectiveness. Participants undergo viral load testing through various methods including PCR and respiratory panels at baseline and multiple time points up to six months after the first infusion. They will be followed for six months post-infusion, with additional safety monitoring for graft-versus-host disease and adverse events if they receive more than one infusion. Medical records may be reviewed for up to one year after the last infusion to collect further data. The main outcomes measured include severe graft-versus-host disease and serious adverse events within the first 30 to 90 days after treatment.
CONDITIONS
Brief Title
Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from patient, parent, or legal guardian.
- Male or female, 1 month through 65 years old at time of consent.
- Prior allogeneic hematopoietic stem cell transplant and/or solid organ transplant, or diagnosis of primary immunodeficiency, or current/recent immunosuppressive therapy for cancer or autoimmune disease.
- If on steroids, able to reduce dose to less than 1 mg/kg/day prednisone or equivalent before infusion.
- Negative pregnancy test for females aged 10 years or older or who have reached menarche, unless surgically sterilized or post-menopausal.
- Diagnosis of adenovirus, cytomegalovirus, or Epstein-Barr virus infection persistent despite standard therapy, meeting specific infection criteria.
You will not qualify if you...
- Received ATG or Alemtuzumab within 21 days before viral-specific T cell infusion with low T cell survival.
- Active acute graft-versus-host disease grades II-IV.
- Active severe chronic graft-versus-host disease.
- Donor lymphocyte infusion within 21 days before planned viral-specific T cell infusion, except for a fraction of umbilical cord blood.
- Active uncontrolled relapse of malignancy (except EBV+ post-transplant lymphoproliferative disorder or lymphoma).
- Expected start of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.
- Pregnant or breastfeeding patients.
- Other medical problems or medications that may increase risk or interfere with study participation or data quality, as judged by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Variable, depending on number of infusions; infusions occur at minimum 14-day intervals
Participants receive viral specific T-lymphocyte infusions to treat infections. Up to 5 total infusions may be given from up to 2 donors, with additional infusions spaced at least 14 days apart depending on response.
Multiple infusion visits spaced at least 14 days apart
Duration - Up to 6 months post first infusion; extended monitoring up to 1 year after last infusion
Participants are followed for safety and clinical response for 6 months after the first infusion. If additional infusions are given, monitoring continues for 90 days after the last infusion, with data collected up to 1 year after the most recent infusion.
Scheduled visits at 14 days, 1 month, 3 months, and 6 months post infusion; additional visits as needed for safety monitoring
Trial Site Locations
Total: 3 locations
1
Jessie Alexander
Palo Alto, California, United States, 94304
Completed
2
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Actively Recruiting
3
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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