AdenovirusPhase 2NCT03266627
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
A Phase 2 study testing cytotoxic t-lymphocytes in people with Adenovirus and Primary Immune Deficiency Disorder, run by New York Medical College at 10 sites in United States.
Trial summary
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT)… Read more about this study
- Who is it for?
- Ages 1 month to 79 years
- Conditions the study is for
- Adenovirus, Primary Immune Deficiency Disorder
- What is being tested?
- cytotoxic t-lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Nov 2018to 31 Dec 2027
- Phase
- Phase 2
- 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 month to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patients with Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with:
- Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or
- clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR
- Medical intolerance to anti-viral therapies including:
- grade 2 renal insufficiency secondary to cidofovir 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 yrs) Age: 0.1 to 79 years Females of childbearing potential with a negative urine pregnancy test
- Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
- Third Party Related Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor > 1 HLA A, B, DR match to recipient) with a T-cell response at least to the viral MACS® GMP PepTivator antigen(s) of adenovirus. 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:
A patient meeting any of the following criteria is not eligible for the present study:
. Patient with acute GVHD > grade 2 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 Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s) Any medical condition which could compromise participation in the study according to the investigator's assessment Known HIV infection Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
Known hypersensitivity to iron dextran Patients unwilling or unable to comply with the protocol or unable to give informed consent.
Known human anti-mouse antibodies
-
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Children's Hospital of Colorado
Aurora, Colorado, 80045
Michael Verneris, MD, 720-777-1234, Michael.Verneris@childrenscolorado.org
Amanda Kinderman, MPH, 303-724-3652, amanda.kinderman@ucdenver.edu
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Michael Verneris, MD, MICHAEL.VERNERIS@CUANSCHUTZ.EDU
- Not yet recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Kenneth Cooke, MD
- Recruiting
Nationwide Children's Hosptial
Columbus, Ohio, 43205
Dean Lee, MD, PhD, 614-722-3550, Dean.Lee@nationwidechildrens.org
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Emily Hopewell, MD, emlhope@iu.edu
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Neena Kapoor, MD, nkapoor@chla.usc.edu
- Recruiting
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Julie A Talano, MD, 414-955-4185, jtalano@mcw.edu
Meredith Beversdorf, RN, (414) 266-5891, mbeversdorf@mcw.edu
- Recruiting
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nancy Bunin, MD, 215-590-2255, buninn@email.chop.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Julia Chu, MD, Julia.Chu2@ucsf.edu
- Recruiting
Washington University
St Louis, Missouri, 63130
Shalini Shenoy, MD, shalinishenoy@wustl.edu
About this study
Official title: A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
- Conditions
- Adenovirus, Primary Immune Deficiency Disorder
- Being tested
- cytotoxic t-lymphocytes
- Keywords
- adenovirus, primary immune deficiency disorder, cytotoxic t-lymphocytes
- Medical subject headings
- Adenoviridae Infections, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytotoxic t-lymphocytesDrug
Also called viral specific CTLs
adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
| Study group | Role | What they receive |
|---|---|---|
| patients with adenoviral infection | Experimental | patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions. Receives: Drug: cytotoxic t-lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be followed for adverse events following each infusion of ADV CTLs
Measured: 12 weeks after each infusion
Incidence of Response to Treatment (Efficacy)
Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs
Measured: 12 weeks after last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Nov 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenovirusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All eligible patients will receive one dose of CTLs at the same dose. Patients who meet the criteria may need additional CTL doses up to 5 total.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco, University of Colorado, Denver, Indiana University, Washington University School of Medicine, University of California, Los Angeles
- Responsible party
- Principal investigator, Mitchell Cairo, New York Medical College
- Investigators
- Mitchell Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266627
- Sponsor's protocol ID
- NYMC 579
- Other IDs
- FD006363
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2017
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients
- ClinicalTrials.gov ID
- NCT03266627
- Acronym / sponsor ID
- NYMC 579
- Conditions
- Adenovirus, Primary Immune Deficiency Disorder
- Keywords
- adenovirus, primary immune deficiency disorder, cytotoxic t-lymphocytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco, University of Colorado, Denver, Indiana University, Washington University School of Medicine, University of California, Los Angeles
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Aug 2017 (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.
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant.
Funding Source: FDA OOPD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All eligible patients will receive one dose of CTLs at the same dose. Patients who meet the criteria may need additional CTL doses up to 5 total.
| Arm | Type | Receives |
|---|---|---|
| patients with adenoviral infection | Experimental | Drug: cytotoxic t-lymphocytespatients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions. |
Who may qualify
- Ages
- 1 month to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 |
|---|---|---|
| cytotoxic t-lymphocytesAlso: viral specific CTLsadenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID. | Drug | patients with adenoviral infection |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12 weeks after each infusion
Patients will be followed for adverse events following each infusion of ADV CTLs
Incidence of Response to Treatment (Efficacy)
Time frame: 12 weeks after last infusion
Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs
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 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytotoxic t-lymphocytes in people with Adenovirus and Primary Immune Deficiency Disorder, run by New York Medical College at 10 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 12 weeks after each infusion). The study lists 2 primary outcomes in all. 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 23 Oct 2026.