Is NCT04722029 recruiting in Columbus, OH?

Yes, NCT04722029 is currently recruiting participants at its Columbus, OH location. This adenovirus infection clinical trial is actively enrolling qualified participants.

How do I join the adenovirus infection clinical trial in Columbus?

To join this clinical trial in Columbus, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Columbus clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Adenovirus Infection Clinical Trial in Columbus, OH

About This Adenovirus Infection Study in Columbus

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.

Sponsor: Nationwide Children's Hospital

Who Can Participate

Inclusion 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 organ injury.

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.

Exclusion Criteria

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 symptoms will not be interpreted as progressing infection

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 half-life of BCV (8 to 12 hours). Any medical condition which could compromise participation in the study according to the investigator's assessment

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Columbus?

Yes, this clinical trial (NCT04722029) has an active research site in Columbus, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Adenovirus Infection Treatment Options in Columbus, OH

If you're searching for adenovirus infection treatment options in Columbus, OH, this clinical trial (NCT04722029) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Columbus research site is actively enrolling participants for this clinical trial. You'll receive care from experienced adenovirus infection specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all adenovirus infection clinical trials near you to find additional studies recruiting in your area.

Adenovirus Infection Clinical Trial in Columbus, OH

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