Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

NCT03266627 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NYMC 579FD006363
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Adenovirus; Primary Immune Deficiency Disorder

Keywords

adenovirus; primary immune deficiency disorder; cytotoxic t-lymphocytes

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Patients will be followed for adverse events following each infusion of ADV CTLs

  12 weeks after each infusion

• Incidence of Response to Treatment (Efficacy)

  Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs

  12 weeks after last infusion

Study Arms (1)

patients with adenoviral infection

EXPERIMENTAL

patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.

Drug: cytotoxic t-lymphocytes

Interventions

cytotoxic t-lymphocytes DRUG

adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.

Also known as: viral specific CTLs

patients with adenoviral infection

Eligibility Criteria

• Age: 1 Month - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• A patient meeting any of the following criteria is not eligible for the present study:
• 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

Sponsors & Collaborators

• New York Medical College: lead
• Children's Hospital of Philadelphia: collaborator
• Medical College of Wisconsin: collaborator
• Nationwide Children's Hospital: collaborator
• Johns Hopkins University: collaborator
• University of California, San Francisco: collaborator
• University of Colorado, Denver: collaborator
• Indiana University: collaborator
• Washington University School of Medicine: collaborator
• University of California, Los Angeles: collaborator

Study Sites (10)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Nationwide Children's Hosptial

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Adenoviridae Infections; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Cairo, MD

CONTACT

914-594-2150; mitchell_cairo@nymc.edu

Lauren Harrison, RN

CONTACT

617-285-7844; lauren_harrison@nymc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All eligible patients will receive one dose of CTLs at the same dose. Patients who meet the criteria may need additional CTL doses up to 5 total.

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: November 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (10)