R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06926894
Phase
PHASE1
Status
Recruiting
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Conditions

  • Adenovirus
  • BK Virus Infection
  • Cytomegalovirus Infections
  • Epstein-Barr Virus
  • Immune Deficiency

Eligibility Criteria

Sex
ALL
Age
3 Months - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Rapidly generated virus specific T (R-MVST) cells — DRUG
    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 Details

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.

Key Dates

Start date
Apr 20, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical Center / New-York PresbyterianNew YorkNew York10032
Prakash Satwani, MD
[email protected]
212-305-0223
Prakash Satwani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Medical Center / New-York Presbyterian· New York, NY

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