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CAR T-cell Therapy
T-lymphocyte Therapy for Adenovirus Infections (ADV-VSTS Trial)
Phase 1 & 2
Recruiting
Led By Eunkyung Song, MD
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-28 days
Awards & highlights
ADV-VSTS Trial Summary
This trial will assess the safety and efficacy of adenovirus-specific T lymphocytes isolated from blood or leukapheresis products, generated by the CliniMACS Prodigy.
Who is the study for?
This trial is for people with stubborn adenovirus infections who can't tolerate antiviral drugs due to kidney or bone marrow issues, or have had organ transplants. It's open to ages 0-60 and includes those on recent chemotherapy or immunosuppressants. Pregnant women and those with uncontrolled infections, HIV, or certain drug treatments are excluded.Check my eligibility
What is being tested?
The study tests adenovirus-specific T lymphocytes from related donors to see if they're safe and effective against tough-to-treat adenovirus infections. These special immune cells are prepared using a system that selects them based on their response to specific viral parts.See study design
What are the potential side effects?
Potential side effects aren't detailed here but could include reactions related to the immune system's response to the infused T-cells, such as fever, fatigue, headache, muscle pain, and possible worsening of infection symptoms.
ADV-VSTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an organ disease not responding to antiviral treatment for over 14 days.
Select...
I cannot tolerate anti-viral medications due to kidney issues, low blood counts, severe diarrhea, or other organ damage.
ADV-VSTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7-28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy by measuring viral load
Safety by measuring unacceptable toxicities
ADV-VSTS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RecipientExperimental Treatment1 Intervention
Recipient will undergo a screening period that will include history and physical examination, laboratory tests, performance status, HLA typing and pregnancy test (if needed).
Qualified patients will receive ADV-VSTS infusion from haploidentical donors up to a maximum of 5.0 x 104 interferon gamma-negative cells/kg. All patients will be followed for laboratory and clinical response, safety, efficacy and tolerance.
Group II: DonorActive Control1 Intervention
Donors will be evaluated to determine suitability to undergo apheresis collection and their infectious disease status. Donor evaluation will include history and physical examination, laboratory tests, FDA- approved donor testing of communicable diseases (HIV, HVB, HCV, HTLV-I, II, WNV, T. pallidum, T. cruzi, and Zika virus), ABO and Rh typing, pregnancy tests, and donor serology for ADV.
Qualified donors will undergo leukapheresis. Collection will proceed for 2 hours or 2 blood volumes, whichever occurs first.
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Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,494 Total Patients Enrolled
Eunkyung Song, MDPrincipal InvestigatorNationwide Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking a high dose of steroids.I am on anti-fungal treatment and have shown improvement or stability for a week.I received an organ transplant more than 28 days ago.I am between 0 days and 60 years old.You have a known allergy to iron dextran.I am not pregnant, breastfeeding, and I agree to use birth control during the study.I have cancer and received chemotherapy in the last 6 months.I am at high risk for viral infections due to my medical history or recent medication changes.I have an organ disease not responding to antiviral treatment for over 14 days.My health severely limits my daily activities.I am on a final treatment for a bacterial infection and have shown no worsening signs for 3 days.You have an autoimmune or autoinflammatory condition that is not related to a primary immunodeficiency.My ADV infection has not improved despite treatment for over 14 days.I do not have any infections that are not under control.My infection is getting worse, shown by unstable blood pressure due to sepsis or new/worsening symptoms.I am HIV positive.You have a medical condition that could prevent you from participating in the study, as determined by the researcher.I have received a stem cell transplant from a donor.I stopped taking brincidofovir at least 72 hours before my planned treatment.I cannot tolerate anti-viral medications due to kidney issues, low blood counts, severe diarrhea, or other organ damage.I have not taken any immune-suppressing drugs in the last 30 days.I haven't taken any T-cell depleting drugs or certain antibodies in the last 28 days.You are currently participating in another experimental clinical trial for treating adenovirus infection.You do not have any known conditions that weaken your immune system.You must fulfill at least one of the following requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Recipient
- Group 2: Donor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants in this research project?
"That is correct. The listing for this clinical trial on clinicaltrials.gov shows that the study is currently looking for 12 patients from 1 site."
Answered by AI
Are there any current vacancies in this trial for new participants?
"The trial, which is still recruiting patients according to clinicaltrials.gov, was originally posted on October 1st 2021. The study's most recent update was on September 1st of this year."
Answered by AI
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