R-MVST Cells for Treatment of Viral Infections

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

Sponsor
Columbia University
Study ID
NCT05183490
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rapidly generated virus specific T (R-MVST) cells — DRUG
    The R-MVST products will be manufactured individually for each patient from a selected donor; it is an anti-viral prophylaxis and treatment of viral reactivation. SCT dose escalation: Cohort / R-MVST dose * (-1A) 0.25x10\^6 R-MVST TNC/kg * (1A) 0.5x10\^6 R-MVST TNC/kg * (2A) 1x10\^6 R-MVST TNC/kg SOT dose escalation: Cohort / R-MVST dose * (-1B) 1x10\^6 R-MVST TNC/kg * (1B) 2x10\^6 R-MVST TNC/kg * (2B) 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
May 3, 2022
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Allogenic Stem Cell Transplant Recipient (SCT)
    Dose levels selected for Group A are based on previous experience with VST cells in HCT recipients and are lower than in Group B (SOT recipients), as donor-derived R-MVST cells are more likely to persist in recipients of HCT from the same donors. Thus, there is theoretically a higher risk for development of GVHD in this subset of patients. Each group will undergo independent dose escalation. Subjects will receive a single dose of R-MVST Cells, and followed for toxicity and GVHD for 28 days days after infusion. Up to two additional doses may be administered, minimum of 28 days apart if cohort safety is established and reinfusion criteria are met. A new 28-day safety-monitoring period will ensue for each additional infusion. Subjects will be followed for possible virological and clinical responses for up to 1 year after the initial R-MVST infusion.
  • Experimental: Group B: Solid organ transplant recipients (SOT)
    In SOT recipients, the study will use higher doses of R-MVST cells, as the infused anti-viral T cells are less likely to persist long-term and cause GVHD, based on the safety profile of PyVST cells used for therapy of PML in non-HCT subjects. Subjects will receive a single dose of R-MVST Cells, and followed for toxicity and GVHD for 28 days days after infusion. Up to two additional doses may be administered, minimum of 28 days apart if cohort safety is established and reinfusion criteria are met. A new 28-day safety-monitoring period will ensue for each additional infusion. Subjects will be followed for possible virological and clinical responses for up to 1 year after the initial R-MVST infusion.

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 Irving Medical CenterNew YorkNew York10032
Pawel Muranski, MD
[email protected]
212-305-9326
Pawel Muranski, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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