Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT04691622
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Primary Immunodeficiency Disorders (PID)
  • Viral Infection

Eligibility Criteria

Sex
ALL
Age
3 Months - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Norovirus -specific T-cell (NST) therapy — BIOLOGICAL
    Arm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion. Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.

Study Details

This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.

Key Dates

Start date
Mar 17, 2022
Status verified
Jan 2026
Primary completion
Aug 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Norovirus -specific T-cell (NST) therapy for chronic norovirus infection
    This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or with primary immunodeficiency disorders (PID) who have not undergone HSCT. There are two arms in this study: 1. Arm A: Participants who receive donor-derived NST therapy after HSCT 2. Arm B: Participants who receive partially HLA matched NSTs. The following participants apply: * Participants with PID who have not undergone HSCT. * Participants who have undergone HSCT but do not have available donor derived NSTs, or those for whom NSTs cannot be generated due to norovirus seronegativity. * Participants who have undergone SOT.

Primary Outcome Measure

Incidence of acute GvHD (grade III-IV) [ Time Frame: Within 45 days of first NSTs infusion ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Michael Keller, MD
[email protected]
202-476-5843
Fahmida Hoq, MBBS, MS
[email protected]
202-476-3634
Michael Keller, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Robin Avery, MD
[email protected]
4432874694
Robin Avery, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of Health (NIH)BethesdaMaryland20892
Alison Han, MD
[email protected]
301-480-5722
Alison Han, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's National Hospital· Washington D.C., DCJohns Hopkins University· Baltimore, MDNational Institutes of Health (NIH)· Bethesda, MD

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