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

NCT07225972 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NYMC 622
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CMV; AdV Infection; AdV Reactivation; Adenovirus; Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• Viral PCR to determine resolution of disease

  Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.

  Day 100

Study Arms (2)

Standard of Care Medication

ACTIVE COMPARATOR

Patients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician.

Drug: Standard of Care Antiviral medications

Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)

EXPERIMENTAL

Patients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs.

Drug: Standard of Care Antiviral medications; Biological: Viral CTLs

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)

Standard of Care Medication; Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)

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

Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)

Eligibility Criteria

• Age: 1 Day - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Patient with acute GVHD \> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion.
• Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CTL infusion.
• Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion.
• Patient with poor performance status determined by Karnofksy (patients \> 16 yrs) or Lansky (patients \< 16 years) score \< 30%.
• Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections.
• Any known medical condition which cold compromise participation in the study according to investigators assessment.
• Known AIDS or uncontrolled HIV infection
• Known hypersensitivity to iron dextran
• Encephalitis and/or retinitis

Sponsors & Collaborators

• New York Medical College: lead

MeSH Terms

Conditions

Adenoviridae Infections; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Herpesviridae Infections

Study Officials

• Mitchell Cairo, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Cairo, MD

CONTACT

914-594-2150; mitchell_cairo@nymc.edu

Lauren Harrison, RN

CONTACT

617-285-7844; lauren_harrison@nymc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, open-label, randomized trial allocating patients to CTLs+SOC and SOC only at a 2:1 ratio. Patients will be enrolled to two cohorts, Cohort 1, ADV and Cohort 2, CMV. For patients with progressive viremia/disease (PD) in the SOC arm, crossover will be allowed to receive CTLs from an eligible family related donor that has screened positive to the specific viral PepTivator.

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share