12 Participants Needed

T-lymphocyte Therapy for Adenovirus Infections

(ADV-VSTS Trial)

MT
Overseen ByMelinda Triplet
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

ES

Eunkyung Song, MD

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent and/or signed assent line from patient, parent or legal guardian prior to any study-related procedures.
Negative pregnancy test in female patients if applicable (childbearing potential)
I received an organ transplant more than 28 days ago.
See 10 more

Exclusion 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.
You have a known allergy to iron dextran.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Qualified patients receive ADV-VSTS infusion from haploidentical donors

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy, including viral load and adverse events

4 weeks
Weekly visits (in-person)

Long-term follow-up

Participants may continue to be monitored for long-term safety and efficacy

Ongoing

Treatment Details

Interventions

  • Adenovirus Specific T lymphocytes
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
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Recruited
5,228,000+
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