Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)

NCT03266640 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NYMC 580FD006363
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Cytomegalovirus Infections; Primary Immune Deficiency Disorder

Keywords

Cytomegalovirus; CMV; cytotoxic t-lymphocytes

Outcome Measures

Primary Outcomes (2)

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

  Patients will be monitored for adverse events following the administration of CMV CTLs

  Patients will be followed for 12 weeks after each infusion

• Incidence of Response to Treatment

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

  Patients will be followed 12 weeks after each infusion

Study Arms (1)

Refractory CMV

EXPERIMENTAL

Patients with refractory CMV will be given one dose of CMV specific CTLs. HLA matched donors will get Dose 2.5 × 10(4) CD3/kg recipient weight; HLA mismatched will get 0.5x10(4) CD3/kg recipient weight. Additional doses may be given for a total of 5 doses if patients do not have a response to the first dose with a reduction in viral load to normal limits.

Drug: viral specific cytotoxic t-lymphocytes

Interventions

viral specific cytotoxic t-lymphocytes DRUG

CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.

Also known as: CMV CTLs

Refractory CMV

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 CMV CTL infusion Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CMV CTL infusion Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CMV CTL infusion Thymoglobulin (ATG), Alemtuzumab or T cell immunosuppressive monoclonal antibodies within 30 days Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% CMV retinitis Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory CMV infection.
• 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 CMV retinitis, meningitis, encephalitis, and/or cerebritis

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
• Washington University School of Medicine: collaborator
• Indiana University: collaborator
• Children's Hospital Los Angeles: collaborator

Study Sites (9)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

New York Medical College

Valhalla, New York, 10595, 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

Cytomegalovirus Infections; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Herpesviridae Infections; 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 S Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell S Cairo, MD

CONTACT

914-594-2150; mitchell_cairo@nymc.edu

Lauren Harrison, RN

CONTACT

6172857844; 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 be given CMV specific CTLs and dose is based on donor source: HLA matched and HLA mismatced

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 (9)