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Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients

NCT03266627•New York Medical College

View on ClinicalTrials.gov

Summary

Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD

Eligibility

Age

0 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:
•* Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
•* clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR
•* Medical intolerance to anti-viral therapies including:
•* grade 2 renal insufficiency secondary to cidofovir Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
•Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) Age: 0.1 to 79 years
•Females of childbearing potential with a negative urine pregnancy test
•2. Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
•a. Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
•AND Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
+1 more criteria

Exclusion Criteria

•. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s) 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
•\-

Locations (10)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

University of Colorado Denver

Aurora, Colorado, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

Nationwide Children's Hosptial

Columbus, Ohio, United States

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

November 1, 2018

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

August 8, 2025

Enrollment

ESTIMATED participants

Conditions

AdenovirusPrimary Immune Deficiency Disorder

Interventions

cytotoxic t-lymphocytes

DRUG

Contacts

Mitchell Cairo, MD

CONTACT

914-594-2150 mitchell_cairo@nymc.edu

Lauren Harrison, RN

CONTACT

617-285-7844 lauren_harrison@nymc.edu

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

NCT05664126

CytomegalovirusAdenovirus

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R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

NCT06926894

Epstein-Barr VirusCytomegalovirus Infections+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

Inclusion Criteria

Exclusion Criteria

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

Allogeneic Multivirus - Directed Cytotoxic T Lymphocytes (CTL)

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant