NCT07225972 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 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | New York Medical College |
| Condition | CMV |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2031-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 138 participants in total. It began in 2026-09-01 with a primary completion date of 2031-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mitchell Cairo, MD
PRINCIPAL INVESTIGATOR
New York Medical College
Frequently Asked Questions
Who can join the NCT07225972 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 30 Years, studying CMV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225972 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 138 participants.
Is NCT07225972 currently recruiting?
Yes, NCT07225972 is actively recruiting participants. Contact the research team at mitchell_cairo@nymc.edu for enrollment information.
Where is the NCT07225972 trial being conducted?
This trial is being conducted at Valhalla, United States, Milwaukee, United States.
Who is sponsoring the NCT07225972 clinical trial?
NCT07225972 is sponsored by New York Medical College. The principal investigator is Mitchell Cairo, MD at New York Medical College. The trial plans to enroll 138 participants.