Actively Recruiting
Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity
Led by Jessie L. Alexander · Updated on 2025-08-14
25
Participants Needed
3
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic 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. In this trial, we 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.
CONDITIONS
Official 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 or assent given according to FDA guidelines
- Male or female aged 1 month through 65 years at consent
- Prior allogeneic hematopoietic stem cell transplant and/or prior solid organ transplant and/or diagnosis of primary immunodeficiency and/or current or recent immunosuppressive therapy for cancer or autoimmune disease
- Able to taper steroids to less than 1 mg/kg/day prednisone or equivalent before cell infusion
- Negative pregnancy test for females 10 years or older or post-menopausal or surgically sterilized
- Diagnosis of adenovirus, CMV, or EBV infection persistent despite standard therapy
- For adenovirus infection, must have active infection demonstrated by biopsy or culture/PCR plus worsening symptoms despite antiviral therapy, or refractory adenoviremia, or intolerance to antivirals
- For CMV infection, must have active infection demonstrated by biopsy or culture/PCR plus worsening symptoms despite antiviral therapy, or refractory CMV viremia, or intolerance to antivirals
- For EBV infection, must have EBV DNAemia persistent despite rituximab, biopsy-proven lymphoma with EBV, compatible clinical findings with elevated viral load, failure of antiviral or anti-CD20 therapy, or intolerance to rituximab
You will not qualify if you...
- Received ATG or Alemtuzumab within 21 days before viral-specific T cell infusion with low T cell counts (<10 CD3+ cells/uL)
- Active acute graft-versus-host disease grades II-IV
- Active severe chronic graft-versus-host disease
- Received donor lymphocyte infusion within 21 days before T cell infusion (except fraction of umbilical cord blood)
- Active uncontrolled relapse of malignancy other than EBV+ post-transplant lymphoproliferative disorder or lymphoma
- Expected to start new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion
- Pregnant or lactating patients
- Other medical or laboratory conditions or medications that pose additional risks or interfere with study participation or data quality as judged by the investigator
AI-Screening
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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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