Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone

Part of paid clinical trials in Valhalla, New York.

Sponsor
New York Medical College
Study ID
NCT07225972
Phase
PHASE3
Status
Recruiting
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Conditions

  • AdV Infection
  • AdV Reactivation
  • Adenovirus
  • CMV
  • Cytomegalovirus Infections

Eligibility Criteria

Sex
ALL
Age
1 Day - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Antiviral medications — DRUG
    Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)
  • Viral CTLs — BIOLOGICAL
    ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions

Study Details

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.

Key Dates

First listed
Nov 10, 2025
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Dec 1, 2031
Completion
Dec 1, 2032

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care Medication
    Patients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician.
  • Experimental: Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)
    Patients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs.

Primary Outcome Measure

Viral PCR to determine resolution of disease [ Time Frame: Day 100 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New York Medical CollegeValhallaNew York10595
Mitchell S Cairo, MD
[email protected]
914-594-2150
Lauren Harrison, RN, MSN
[email protected]
6172857844
Mitchell S Cairo, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Julie An Talano, MD
[email protected]

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