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

NCT ID: NCT07225972

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-01

Study Completion Date

2032-12-01

Brief Summary

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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.

Detailed Description

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We hypothesize that Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) manufactured by direct selection utilizing the CliniMACS Prodigy® and Cytokine Capture System® plus standard of care (SOC) vs SOC alone in children, adolescents and young adults (CAYA) following allogeneic hematopoietic stem cell transplantation (HSCT) with medically refractory viral infection/viremia and/or intolerant or resistant to anti-viral antibiotic therapy will be associated with a significantly improved probability of Day +100 (time of onset on study) viral progression free survival (VPFS).

Conditions

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CMV AdV Infection AdV Reactivation Adenovirus Cytomegalovirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care Medication

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

Group Type ACTIVE_COMPARATOR

Standard of Care Antiviral medications

Intervention Type 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 plus Cytotoxic T-Lymphocytes (CTLs)

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

Group Type EXPERIMENTAL

Standard of Care Antiviral medications

Intervention Type DRUG

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

Viral CTLs

Intervention Type BIOLOGICAL

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

Interventions

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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)

Intervention Type DRUG

Viral CTLs

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Medical College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Cairo, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College

Central Contacts

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Mitchell Cairo, MD

Role: CONTACT

Phone: 914-594-2150

Email: [email protected]

Lauren Harrison, RN

Role: CONTACT

Phone: 617-285-7844

Email: [email protected]

Other Identifiers

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NYMC 622

Identifier Type: -

Identifier Source: org_study_id