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New treatment option for Adenovirus
Official title Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity
ClinicalTrials.gov ID: NCT06909110
What this study is testing
What is Adenovirus Specific T- Lymphocytes?
Adenovirus Specific T- Lymphocytes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenovirus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 65
You may be able to join if
- Patient 1. Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age...
- Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant, AND/OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, pancreatic...
- If receiving steroids, must be able to taper dose to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized or post-menopausal.
You likely can't join if
- Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \<10 CD3+ T...
- Active acute GVHD grades II-IV.
- Active severe chronic GVHD.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell...
- Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).
- Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.
See the full eligibility criteria
Who can join
- Patient 1. Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if...
- Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.
- Prior allogeneic hematopoietic stem cell transplant, AND/OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, pancreatic, and/or multivisceral), AND/OR diagnosis of primary immunodeficiency...
- If receiving steroids, must be able to taper dose to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.
- Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized or post-menopausal.
- Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy. A. Adenovirus Infection or Disease (at minimum, one of the below sub-criteria must be met):
- 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...
- Refractory adenoviremia: defined as DNAemia ≥1000 copies/mL or \<1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)
- Intolerance of or contraindication to antiviral medications. B. CMV Infection or Disease (at minimum, one of the below sub-criteria must be met):
- 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...
- Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥1,000 IU/mL or \<1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other...
- Intolerance of or contraindication to antiviral medications. C. EBV Infection or Disease (at minimum, one of the below sub-criteria must be met):
- EBV DNAemia ≥1000 IU/mL, persistent despite 2 doses of rituximab,
- Biopsy proven lymphoma or lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR,
- Clinical or imaging findings consistent with EBV lymphoma or lymphoproliferation with current or recent elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk,
- Failure of antiviral therapy, as determined by one of the two bullets below after two weeks of anti-CD20 targeted therapy such as rituximab, i. There was an increase or less than 50% response at sites of lymphoma...
- Intolerance or contraindication to rituximab. Patient
What rules you out
- Received ATG or Alemtuzumab within 21 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.
- Active severe chronic GVHD.
- Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. people receiving a fraction of an umbilical cord blood within 21...
- Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).
- Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.
- Patients who are pregnant or lactating.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to...
- Age ≥ 12\
- Able to understand and sign the consent/assent to the procedure
- Partial (2/6 or more) HLA match to the recipient
- A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors:
- Related to the recipient
- Apheresis does not need a blood prime before the procedure
- Adequate peripheral venous access
- Explicit evaluation of the donors' willingness to donate cells, as attested by the research team
- Must have understanding that they are helping their ill relative, as attested by the research team
- Will gain emotional/psychological benefit from their ability to help and want to donate for a relative, as attested by the research team
- Inclusion of minor donors that are not relatives of the recipient will need to be evaluated on a case-by-case basis for the IRB to evaluate the potential benefit to these participants (whether they will receive an...
- Donor is pregnant
- Donor is HIV positive
- Donor is positive for hepatitis B and/or hepatitis C
- Deemed to be a high-risk donor based on responses to donor risk questionnaire
- Deemed high risk due to preexisting medical condition or abnormal lab results
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.