Recruiting
Phase 1

R-MVST Cells

Sponsor:

Monica Bhatia

Code:

NCT06926894

Conditions

Epstein-Barr Virus

Cytomegalovirus Infections

Adenovirus

BK Virus Infection

Immune Deficiency

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Interventions

Rapidly generated virus specific T (R-MVST) cells

Study Details

Brief 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. 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.

Conditions

Epstein-Barr Virus

Cytomegalovirus Infections

Adenovirus

BK Virus Infection

Immune Deficiency

Study ID

NCT06926894

Start date

Apr 20, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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".

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A: Allogenic Stem Cell Transplant Recipients

Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of hematopoietic stem cell transplant.

experimental: Group B: Solid Organ Transplant Recipients

Patients who have infection due to cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus or BK virus, and are recipients of solid organ transplant.

experimental: Group C: Other Immunocompromised Patients

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.

Interventions

Rapidly generated virus specific T (R-MVST) cells

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

Primary outcome measure

  • Incidence of toxicity that leads to safety endpoint [ Time Frame: Up to 28 days post R-MVST infusion ]
  • Incidence of GVHD post-infusion that leads to safety endpoint [ Time Frame: Up to 28 days post R-MVST infusion ]

Central Contacts and Locations

Central contacts

Haneen Aljayyousi

xxxxxxxxxxha2648@cumc.columbia.edu

Locations

Columbia University Medical Center / New-York Presbyterian

Recruiting

New York, New York, United States, 10032

Contacts

Haneen Aljayyousi

ha2648@cumc.columbia.edu

Principal Investigator:

Monica Bhatia, MD

More Information

Sponsor

Monica Bhatia

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Monica Bhatia on 2026-07-30.