Actively Recruiting
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Led by New York Medical College · Updated on 2025-08-08
20
Participants Needed
9
Research Sites
478 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with refractory CMV infection after allogeneic hematopoietic stem cell transplantation, primary immunodeficiencies, or solid organ transplant
- Persistent or increasing CMV DNA despite two weeks of antiviral therapy or intolerance to antiviral drugs
- ANC below 500/mm2 due to ganciclovir toxicity or renal toxicity with foscarnet
- Known resistance to ganciclovir and/or foscarnet
- Written informed consent by patient or legal representative
- Performance status above 30% (Lansky for under 16 years, Karnofsky for over 16 years)
- Age between 0.1 and 79.99 years
- Females of childbearing potential must have a negative pregnancy test
- Related donor available with T-cell response to CMV antigens
- Third-party related donor allowed if original donor unavailable, with at least one HLA match and positive CMV IgG or T-cell response
- Donor disease screening completed and informed consent obtained
You will not qualify if you...
- Acute graft-versus-host disease (GVHD) above grade 2 or extensive chronic GVHD at time of CTL infusion
- Receiving steroids above 0.5 mg/kg prednisone equivalent at time of CTL infusion
- Donor lymphocyte infusion within 4 weeks prior to CTL infusion
- Use of thymoglobulin, alemtuzumab, or T cell immunosuppressive antibodies within 30 days
- Poor performance status (Karnofsky or Lansky score 30% or below)
- CMV retinitis, meningitis, encephalitis, or cerebritis
- Participation in another experimental trial for refractory CMV infection
- Medical conditions compromising study participation
- Known HIV infection
- Pregnant or breastfeeding females or unwillingness to use birth control
- Known hypersensitivity to iron dextran
- Inability or unwillingness to comply with protocol or give informed consent
- Presence of known human anti-mouse antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
6
New York Medical College
Valhalla, New York, United States, 10595
Actively Recruiting
7
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Actively Recruiting
8
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Mitchell S Cairo, MD
CONTACT
L
Lauren Harrison, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here