CMVPhase 3NCT07225972
Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone
A Phase 3 study testing Viral CTLs in people with CMV and AdV Infection, run by New York Medical College at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 years
- Conditions the study is for
- CMV, AdV Infection, AdV Reactivation
- What is being tested?
- Viral CTLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2026to 1 Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Julie An Talano, MD, jtalano@mcw.edu
- Recruiting
New York Medical College
Valhalla, New York, 10595
Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu
Lauren Harrison, RN, MSN, 6172857844, lauren_harrison@nymc.edu
About this study
Official title: An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection/Viremia
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.
Read the detailed description
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
- CMV, AdV Infection, AdV Reactivation, Adenovirus, Cytomegalovirus Infections
- Being tested
- Standard of Care Antiviral medications, Viral CTLs
- Keywords
- CMV infection, ADV Infection, cytomegalovirus, adenovirus
- Medical subject headings
- Adenoviridae Infections, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Antiviral medicationsDrug
Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)
Viral CTLsBiological
ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Medication | Active comparator | Patients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician. Receives: 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. Receives: Drug: Standard of Care Antiviral medications; Biological: Viral CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral PCR to determine resolution of disease
Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Sep 2026
- Primary completion1 Dec 2031 (estimated)
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225972
- Sponsor's protocol ID
- NYMC 622
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection/Viremia
- ClinicalTrials.gov ID
- NCT07225972
- Acronym / sponsor ID
- NYMC 622
- Conditions
- CMV, AdV Infection, AdV Reactivation, Adenovirus, Cytomegalovirus Infections
- Keywords
- CMV infection, ADV Infection, cytomegalovirus, adenovirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Dec 2031 (estimated)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Medication | Active comparator | Drug: Standard of Care Antiviral medicationsPatients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician. |
| Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs) | Experimental | Drug: Standard of Care Antiviral medications, Biological: Viral CTLsPatients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs. |
Who may qualify
- Ages
- 1 day to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Antiviral medicationsStandard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2) | Drug | Standard of Care Medication, Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs) |
| Viral CTLsADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions | Biological | Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs) |
Primary outcome
Viral PCR to determine resolution of disease
Time frame: Day 100
Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Cairo, MD principal investigator
New York Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viral CTLs in people with CMV and AdV Infection, run by New York Medical College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mitchell Cairo, MD (914-594-2150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral PCR to determine resolution of disease (time frame: Day 100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.