Recruiting
Phase 3

CTLs vs. SOC

Sponsor:

New York Medical College

Code:

NCT07225972

Conditions

CMV

AdV Infection

AdV Reactivation

Adenovirus

Cytomegalovirus Infections

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Standard of Care Antiviral medications

Viral CTLs

Study Details

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

Study ID

NCT07225972

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 1, 2032

Anticipated

Primary completion date

Dec 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Patient Eligibility Cohort 1 (ADV) -Patients with ADV viremia (Cohort 1) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND/OR Medical intolerance to anti-viral therapies including one or more of the following: > grade 2 renal insufficiency secondary to cidofovir and/or other > grade 2 toxicities secondary to cidofovir AND/OR Known resistance to cidofovir

Patient Eligibility (Cohort 2) (CMV)

-Patients with CMV viremia with one or more of the following: Increasing or persistent CMV RT-PCR DNA (>1000 copies) after 7 days of appropriate anti-viral therapy AND/OR Medical intolerance to anti-CMV antibiotic therapies: ANC < 500/mm3 secondary to ganciclovir AND/OR > grade 2 renal toxicity secondary to either foscarnet or cidofovir AND/OR Known resistance to ganciclovir and/or foscarnet

  • Consent: written informed consent given (by patient or legal representative) prior to any study related procedures
  • Performance Status >30% (Lansky < 16 yrs and Karnofsky > 16 years (BOTH COHORTS)
  • Age: 0.01 to 30.00 years (BOTH COHORTS)
  • Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS)
  • Family related donor (> 3 HLA match) that screens positive for ADV5 MACS Peptivator (Cohort 1) or PP65CMV MACS Peptivator (Cohort 2)

Donor Eligibility

  • Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is >0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2).
  • Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor > 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND
  • Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND
  • Obtained informed consents by donor or donor legally authorized representative prior to donor collection

Patient Exclusion Criteria (Both Cohorts)

  • 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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Standard of Care Antiviral medications

Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)

Viral CTLs

ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mitchell Cairo, MD

914-594-2150mitchell_cairo@nymc.edu

Lauren Harrison, RN

617-285-7844lauren_harrison@nymc.edu

Locations

New York Medical College

Recruiting

Valhalla, New York, United States, 10595

Contacts

Mitchell S Cairo, MD

914-594-2150mitchell_cairo@nymc.edu

Lauren Harrison, RN, MSN

6172857844lauren_harrison@nymc.edu

Principal Investigator:

Mitchell S Cairo, MD

More Information

Sponsor

New York Medical College

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • CMV infection
  • ADV Infection
  • cytomegalovirus
  • adenovirus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by New York Medical College on 2026-09-11.