T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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

Sponsor
Children's National Research Institute
Study ID
NCT05141058
Phase
PHASE1
Status
Recruiting
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Conditions

  • SARS-CoV-2 Infection

Eligibility Criteria

Sex
ALL
Age
2 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Coronavirus-specific T cell (CST) — BIOLOGICAL
    Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \<4 months after hematopoietic stem cell transplantation (HSCT).

Study Details

This is an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \<4 months after HSCT). In this dose escalation trial, three doses (1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and \<80 years) HSCT recipients (Arm A) and two arms for pediatric (≥12 years of age and \<18 years; ≥2 years and \<12 years) HSCT recipients (Arm B and Arm C, respectively), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity.

Key Dates

Start date
Oct 19, 2021
Status verified
Mar 2026
Primary completion
Nov 1, 2028
Completion
Dec 15, 2029

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Adults (18 to <80 years)
    Arm A will include adult participants who are at least 18 years of age but younger than 80 years.
  • Experimental: Older children (12 to <18 years)
    Arm B will include adolescent participants who are at least 12 years of age but younger than 18 years.
  • Experimental: Young children (2 to <12 years)
    Arm C will include pediatric participants who are at least 2 years of age but younger than 12 years.

Primary Outcome Measure

Incidence of grade ≥3 infusion-related Adverse Events (AEs) [ Time Frame: Within 45 days of CST infusion ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Susan Conway, MD
[email protected]
202-476-5845
Michael Keller, MD
[email protected]
202-476-5843
Susan Coway, Md (PRINCIPAL_INVESTIGATOR)
Michael Keller, MD (SUB_INVESTIGATOR)
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins UniversityBaltimoreMaryland21287
Tania Jain, MD
[email protected]
4109557035
Tania Jain, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's National Hospital· Washington D.C., DCThe Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University· Baltimore, MD

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