T-lymphocyte Therapy for Adenovirus Infections

(ADV-VSTS Trial)

Overseen by Eunkyung Song, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Nationwide Children's Hospital

No Placebo Group

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

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.

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.

Treatment Details

Interventions

• Adenovirus Specific T lymphocytes (CAR T-cell Therapy)

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

Group I: Recipient Experimental Treatment 1 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: Donor Active Control 1 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.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Catherine Krawczeski

Nationwide Children's Hospital

Chief Medical Officer

MD

Timothy C. Robinson

Nationwide Children's Hospital

Chief Executive Officer since 2019

BSc in Psychology and Business Administration from Indiana University