Actively Recruiting
A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
Led by New York Medical College · Updated on 2025-08-08
20
Participants Needed
9
Research Sites
52 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
Researchers are evaluating virus specific cytotoxic T-lymphocytes (CTLs) for children, adolescents, and young adults with refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation, primary immunodeficiencies, or solid organ transplant. This phase 2 pilot study aims to assess the safety, tolerability, and response to treatment of CMV specific CTLs manufactured using the Miltenyi CliniMACS Prodigy Cytokine Capture System. The study is sponsored by New York Medical College and funded by the FDA OOPD. Participants will receive one dose of CMV specific CTLs derived from HLA matched or mismatched donors. HLA matched donors receive 2.5 x 10^4 CD3 cells per kg of recipient weight, while HLA mismatched donors receive 0.5 x 10^4 CD3 cells per kg. If there is no viral load reduction after the first dose, up to five total doses may be administered. The CTLs are collected, manufactured in a GMP facility, and given to patients with refractory CMV infection. During the study, patients will be followed for 12 weeks after each infusion to monitor treatment-emergent side effects and response to therapy. Researchers will assess safety, tolerability, and changes in viral load. Participants must provide informed consent and comply with study procedures, including donor disease screening and performance status assessments. The total participation duration and monitoring extend through the follow-up period after each infusion.
CONDITIONS
Brief 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 post allogeneic HSCT, primary immunodeficiencies, or post solid organ transplant with increasing or persistent CMV DNA despite two weeks of antiviral therapy or intolerance/resistance to antiviral drugs
- Written informed consent given by patient or legal representative before study procedures
- Performance status greater than 30% (Lansky <16 years and Karnofsky >16 years)
- Age between 0.1 and 79.99 years
- Females of childbearing potential with a negative urine pregnancy test
- Related donor available with T-cell response to CMV MACS GMP PepTivator antigen(s) or suitable third-party donor with family relationship and positive CMV IgG or T-cell response
- Donor disease screening completed and informed consent obtained by donor or legal representative
You will not qualify if you...
- Acute GVHD greater than grade 2 or extensive chronic GVHD at time of CTL infusion
- Receiving steroids higher than 0.5 mg/kg prednisone equivalent at time of infusion
- Donor lymphocyte infusion within 4 weeks before CTL infusion
- Treatment with thymoglobulin, alemtuzumab, or T cell immunosuppressive monoclonal antibodies within 30 days
- Poor performance status (Karnofsky or Lansky score 30% or below)
- CMV retinitis, meningitis, encephalitis, or cerebritis
- Concurrent enrollment in another experimental CMV treatment trial
- Any medical condition compromising study participation as assessed by investigator
- Known HIV infection
- Female patients who are pregnant, breastfeeding, or unwilling to use effective birth control during treatment
- Known hypersensitivity to iron dextran
- Inability or unwillingness to comply with protocol or give informed consent
- Known human anti-mouse antibodies present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks after each infusion
Participants receive one or up to five doses of CMV specific cytotoxic T-lymphocytes depending on response to treatment.
1 infusion visit plus follow-up visits over 12 weeks after each infusion
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
L
Lauren Harrison, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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