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New treatment option for Adenovirus Infection
Official title Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
ClinicalTrials.gov ID: NCT04722029
What this study is testing
What is Adenovirus Specific T lymphocytes?
Adenovirus Specific T lymphocytes is an investigational medicine, being studied as a potential treatment for adenovirus infection.
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
- This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
- 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 up to 60
You may be able to join if
- Age 0 days to 60 years with one of the following conditions:
- Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \> 28 days...
- Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening.
- Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency
- Patients who are receiving or have received systemic immunosuppressive therapies in the 30 days prior to screening including: biologic agents...
You likely can't join if
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from...
- Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment
- Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)
- Evidence of uncontrolled infection (except ADV) as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and evidence of response/stabilization on therapy for 1 week...
See the full eligibility criteria
- Age 0 days to 60 years with one of the following conditions:
- Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \> 28 days post-transplant at the time of screening.
- Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening.
- Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency
- Patients who are receiving or have received systemic immunosuppressive therapies in the 30 days prior to screening including: biologic agents, calcineurin inhibitors, mTOR inhibitors, or corticosteroid
- Patients without known immunocompromised conditions
- And must meet at least 1 of the following criteria.
- Documented ADV refractory infection (i.e., DNAemia detected by qualitative or quantitative PCR in the peripheral blood \> 14 days or rising viral load in blood despite antiviral therapy \>14 days).
- Evidence of refractory ADV end organ disease (proven or probable as previously defined46, including pneumonitis, colitis, hepatitis, hemorrhagic cystitis etc.) despite antiviral therapy \>14 days.
- Medical intolerance to anti-viral therapies including renal toxicity (Cr \>2) and/or bone marrow suppression (ANC \<1500, Hb \<10 and/or Plt \<50) or gastrointestinal manifestation (grade ≥2 diarrhea), or other related...
- At high risk for antiviral failure due to history of recurrent ADV reactivations, or recently started on increased immunosuppressants.
- Negative pregnancy test in female patients if applicable (childbearing potential)
- Written informed consent and/or signed assent line from patient, parent or legal guardian prior to any study-related procedures.
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment
- Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment
- Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)
- Evidence of uncontrolled infection (except ADV) as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and evidence of response/stabilization on therapy for 1 week prior to enrollment
- Progressing infection is defined as hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or...
- Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)
- Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)
- During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.
- If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination...
- Known HIV infection
- Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
- Known hypersensitivity to iron dextran
- Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, 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, up to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.