Epstein-Barr VirusPhase 1NCT06926894
R-MVST Cells for Treatment of Viral Infections in Children and Young Adults
A Phase 1 study testing Rapidly generated virus specific T (R-MVST) cells in people with Epstein-Barr Virus and Cytomegalovirus Infections, run by Monica Bhatia at 1 site in United States.
Trial summary
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. Read more about this study
- Who is it for?
- Ages 3 months to 26 years
- Conditions the study is for
- Epstein-Barr Virus, Cytomegalovirus Infections, Adenovirus
- What is being tested?
- Rapidly generated virus specific T (R-MVST) cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2025to Dec 2030
- Phase
- Phase 1
- 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 3 months to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and young adults (3 months to <26 years) of all ethnic groups will be eligible for the treatment
- Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.
- Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections/reactivations will be eligible as long as at least one of those viral infections meet the criterium of "refractory".
Who cannot join
- Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
- Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.
- Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
- Patients who received extracorporeal photopheresis within the last 28 days.
- Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.
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- Received donor lymphocyte infusion in last 28 days.
- Evidence of GVHD ≥ grade 2
- Evidence of biopsy-proven acute rejection in SOT recipients
- Active and uncontrolled relapse of malignancy
- Patients who are pregnant, or breastfeeding.
- Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.
- Unable or unwilling to receive infusions at Morgan Stanley Children's Hospital.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Medical Center / New-York Presbyterian
New York, New York, 10032
Haneen Aljayyousi, ha2648@cumc.columbia.edu
Monica Bhatia, MD
About this study
Official title: Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.
Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.
Read the detailed description
Starting from childhood, majority of healthy humans are exposed to common viruses such as CMV, EBV, BK and related human polyomaviruses and herpes viruses. Under normal circumstances those infections are well controlled by the adaptive immune system, but never eliminated. Instead, they are fairly inactive and produce relatively few consequences or symptoms. However, when T cell mediated immunity is suppressed, those dormant viruses reactivate and can cause a significant end-organ or severe systemic syndrome. This viral reactivation contributes to morbidity and mortality in recipients of allogeneic stem cell transplant (HCT) and solid organ transplants (SOT), and can affect many other patients who receive immunosuppressive therapies or have underlying pathology that affects T cell function, including patients with autoimmune diseases, congenital immunodeficiencies or HIV/AIDS. As a result of a weakened immune response, conventional antiviral prophylaxis or treatment with acyclovir and ganciclovir/foscarnet (for CMV) or rituximab (against EBV) are not always effective.
The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have conditions that cause poor function of their immune system, such as infections caused by viruses such as Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), BK virus, or adenovirus. The cell product is called rapidly generated virus specific T cells or R-MVST.
This is a single center, Phase 1, non-randomized open-label dose escalation study in three groups of immunocompromised patients. The recipients of allogeneic HCT who will be enrolled in Group A, while SOT recipients will be enrolled in Group B and non-transplanted immunocompromised recipients will be enrolled in Group C. Each group will undergo independent dose escalation.
- Conditions
- Epstein-Barr Virus, Cytomegalovirus Infections, Adenovirus, BK Virus Infection, Immune Deficiency
- Being tested
- Rapidly generated virus specific T (R-MVST) cells
- Medical subject headings
- Epstein-Barr Virus Infections, Cytomegalovirus Infections, Adenoviridae Infections, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapidly generated virus specific T (R-MVST) cellsDrug
Also called R-MVST infusion, total nucleated cells (TNC)
Group A dose escalation schedule:
- Cohort (-1A): 0.25x10^6 R-MVST TNC/kg
- Cohort (1A): 0.5x10^6 R-MVST TNC/kg
- Cohort (2A): 1x10^6 R-MVST TNC/kg
Groups B \& C dose escalation schedule:
- Cohort (-1B) + (-1C): 1x10^6 R-MVST TNC/kg
- Cohort (1B) + (1C): 2x10^6 R-MVST TNC/kg
- Cohort (2B) + (2C): 4x10^6 R-MVST TNC/kg
| Study group | Role | What they receive |
|---|---|---|
| Group A: Allogenic Stem Cell Transplant Recipients | Experimental | Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of hematopoietic stem cell transplant. Receives: Drug: Rapidly generated virus specific T (R-MVST) cells |
| Group B: Solid Organ Transplant Recipients | Experimental | Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of solid organ transplant. Receives: Drug: Rapidly generated virus specific T (R-MVST) cells |
| Group C: Other Immunocompromised Patients | Experimental | Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are immunocompromised for reasons other than hematopoietic stem cell transplant or solid organ transplant. Receives: Drug: Rapidly generated virus specific T (R-MVST) cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicity that leads to safety endpoint
This is to measure the incidence of toxicity post-infusion. Toxicities to consider include: GI toxicity, renal toxicity, hemorrhagic toxicity, cardiovascular toxicity hypotension, cardiac arrhythmia and left ventricular systolic dysfunction), neurological toxicity (somnolence and seizure), coagulation toxicity, vascular toxicity and pulmonary toxicity.
Measured: Up to 28 days post R-MVST infusion
Incidence of GVHD post-infusion that leads to safety endpoint
This is to measure the incidence of GVHD post-infusion. The safety endpoint will be defined as de novo acute GVHD grade IV within 28 days of the last dose of R-MVST, or grades 3-5 infusion related adverse events within 28 days of the last cytotoxic T-lymphocyte (CTL) dose, or grades 4-5 non-hematological adverse events within 28 days of the last CTL dose that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: Up to 28 days post R-MVST infusion
Secondary outcomes (3)
Percentage of subjects with good response in viral load or end-organ disease improvement
This is to measure the effect of R-MVST infusion on viral load and possible recovery of antiviral immunity post-infusion. Subjects with complete response, partial response and stable disease will be tallied.
If patient has end-organ involvement, the disease will be monitored for the evidence of clinical response. In case of post-transplant lymphoproliferative disorder (PTLD)/EBV lymphoma, the standard Cheson criteria will be applied for adult patients.
Measured: Up to 1 year after the initial R-MVST infusion
Overall survival rate
This is to measure the effect of R-MVST infusion on viral load and possible recovery of antiviral immunity post-infusion. The overall survival rate is defined as the percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease, such as cancer.
Measured: Up to 1 year after the initial R-MVST infusion
Incidence of secondary graft failure
Secondary graft failure is defined as initial neutrophil engraftment followed by subsequent decline in the absolute neutrophil count (ANC) to < 500/mm3 for three consecutive measurements on different days, unresponsive to growth factor therapy that persists for at least 14 days in the absence of a known cause such as relapse. Secondary graft failure will be assessed at 28 days post R-MVST infusion in allo-HCT recipients and in recipients of solid organ transplantation.
Measured: Day 28 post R-MVST infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start20 Apr 2025
- Primary completionApr 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr VirusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalations will be performed separately for each group and will employ a classic 3+3 algorithmic design
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monica Bhatia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monica Bhatia, Columbia University
- Investigators
- Monica Bhatia, MD, Principal investigator, Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926894
- Sponsor's protocol ID
- AAAV1433
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2025
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells for Immunodeficient Children and Young Adults
- ClinicalTrials.gov ID
- NCT06926894
- Acronym / sponsor ID
- AAAV1433
- Conditions
- Epstein-Barr Virus, Cytomegalovirus Infections, Adenovirus, BK Virus Infection, Immune Deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Monica BhatiaUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Apr 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.
The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.
Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.
Detailed description
Starting from childhood, majority of healthy humans are exposed to common viruses such as CMV, EBV, BK and related human polyomaviruses and herpes viruses. Under normal circumstances those infections are well controlled by the adaptive immune system, but never eliminated. Instead, they are fairly inactive and produce relatively few consequences or symptoms. However, when T cell mediated immunity is suppressed, those dormant viruses reactivate and can cause a significant end-organ or severe systemic syndrome. This viral reactivation contributes to morbidity and mortality in recipients of allogeneic stem cell transplant (HCT) and solid organ transplants (SOT), and can affect many other patients who receive immunosuppressive therapies or have underlying pathology that affects T cell function, including patients with autoimmune diseases, congenital immunodeficiencies or HIV/AIDS. As a result of a weakened immune response, conventional antiviral prophylaxis or treatment with acyclovir and ganciclovir/foscarnet (for CMV) or rituximab (against EBV) are not always effective.
The main purpose of this study is to test whether giving an experimental cell product can treat the viral infection in patients who have conditions that cause poor function of their immune system, such as infections caused by viruses such as Cytomegalovirus (CMV), Epstein-Barr Virus (EBV), BK virus, or adenovirus. The cell product is called rapidly generated virus specific T cells or R-MVST.
This is a single center, Phase 1, non-randomized open-label dose escalation study in three groups of immunocompromised patients. The recipients of allogeneic HCT who will be enrolled in Group A, while SOT recipients will be enrolled in Group B and non-transplanted immunocompromised recipients will be enrolled in Group C. Each group will undergo independent dose escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalations will be performed separately for each group and will employ a classic 3+3 algorithmic design
| Arm | Type | Receives |
|---|---|---|
| Group A: Allogenic Stem Cell Transplant Recipients | Experimental | Drug: Rapidly generated virus specific T (R-MVST) cellsPatients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of hematopoietic stem cell transplant. |
| Group B: Solid Organ Transplant Recipients | Experimental | Drug: Rapidly generated virus specific T (R-MVST) cellsPatients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of solid organ transplant. |
| Group C: Other Immunocompromised Patients | Experimental | Drug: Rapidly generated virus specific T (R-MVST) cellsPatients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are immunocompromised for reasons other than hematopoietic stem cell transplant or solid organ transplant. |
Who may qualify
- Ages
- 3 months to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children and young adults (3 months to <26 years) of all ethnic groups will be eligible for the treatment
- Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and/or infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.
- Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections/reactivations will be eligible as long as at least one of those viral infections meet the criterium of "refractory".
Key exclusion criteria (15 listed)
- Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Patients who receive corticosteroids at ≥ 0.5mg/kg prednisone or equivalent.
- Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosuppressive monoclonal antibodies in the last 28 days.
- Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.
- Patients who received extracorporeal photopheresis within the last 28 days.
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 |
|---|---|---|
| Rapidly generated virus specific T (R-MVST) cellsAlso: R-MVST infusion, total nucleated cells (TNC)Group A dose escalation schedule: * Cohort (-1A): 0.25x10^6 R-MVST TNC/kg * Cohort (1A): 0.5x10^6 R-MVST TNC/kg * Cohort (2A): 1x10^6 R-MVST TNC/kg Groups B \& C dose escalation schedule: * Cohort (-1B) + (-1C): 1x10^6 R-MVST TNC/kg * Cohort (1B) + (1C): 2x10^6 R-MVST TNC/kg * Cohort (2B) + (2C): 4x10^6 R-MVST TNC/kg | Drug | Group A: Allogenic Stem Cell Transplant Recipients, Group B: Solid Organ Transplant Recipients, Group C: Other Immunocompromised Patients |
Primary outcome
Incidence of toxicity that leads to safety endpoint
Time frame: Up to 28 days post R-MVST infusion
This is to measure the incidence of toxicity post-infusion. Toxicities to consider include: GI toxicity, renal toxicity, hemorrhagic toxicity, cardiovascular toxicity hypotension, cardiac arrhythmia and left ventricular systolic dysfunction), neurological toxicity (somnolence and seizure), coagulation toxicity, vascular toxicity and pulmonary toxicity.
Incidence of GVHD post-infusion that leads to safety endpoint
Time frame: Up to 28 days post R-MVST infusion
This is to measure the incidence of GVHD post-infusion. The safety endpoint will be defined as de novo acute GVHD grade IV within 28 days of the last dose of R-MVST, or grades 3-5 infusion related adverse events within 28 days of the last cytotoxic T-lymphocyte (CTL) dose, or grades 4-5 non-hematological adverse events within 28 days of the last CTL dose that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
3 secondary outcomes
Percentage of subjects with good response in viral load or end-organ disease improvement
Time frame: Up to 1 year after the initial R-MVST infusion
Overall survival rate
Time frame: Up to 1 year after the initial R-MVST infusion
Incidence of secondary graft failure
Time frame: Day 28 post R-MVST infusion
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 30 Jul 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.
Monica Bhatia, MD principal investigator
Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapidly generated virus specific T (R-MVST) cells in people with Epstein-Barr Virus and Cytomegalovirus Infections, run by Monica Bhatia at 1 site 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?
The sponsor lists 3 inclusion and 15 exclusion criteria. 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 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Haneen Aljayyousi (xxxxxxxxxx, ha2648@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicity that leads to safety endpoint (time frame: Up to 28 days post R-MVST 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 30 Jul 2026.