138 Participants NeededMy employer runs this trial

Viral CTLs + Standard Care for Cytomegalovirus Infection

Recruiting at 1 trial location
MC
LH
Overseen ByLauren Harrison, RN
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: New York Medical College
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.

Who Is on the Research Team?

MC

Mitchell Cairo, MD

Principal Investigator

New York Medical College

Are You a Good Fit for This Trial?

This trial is for children and young adults (up to age 30) who have had a stem cell transplant and now have ADV or CMV infections that aren't improving with standard antiviral treatments, can't tolerate these medicines, or the virus is resistant. Participants need a matched family donor available for special immune cells.

Inclusion Criteria

I have an ADV infection after a stem cell transplant and antiviral treatment hasn't worked or caused side effects, or my virus is resistant to cidofovir.
I am part of the group eligible for the CMV study.
I am between 0.01 and 30 years old.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Viral CTLs

Trial Overview

The study compares two groups: one gets standard antiviral medications plus special infection-fighting immune cells from a family donor (viral CTLs), while the other group receives only standard antiviral care. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)Experimental Treatment2 Interventions
Group II: Standard of Care MedicationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York Medical College

Lead Sponsor

Trials
73
Recruited
8,700+