Actively Recruiting

Phase 1
Age: 2Years - 80Years
All Genders
NCT05141058

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

Led by Children's National Research Institute · Updated on 2026-03-12

24

Participants Needed

2

Research Sites

425 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 2 to less than 80 years
  • Recipient of prior myeloablative or non-myeloablative allogeneic HSCT using bone marrow, peripheral blood stem cells, or cord blood 28 days to less than 4 months ago
  • At risk of SARS-CoV-2 infection
  • Evidence of primary engraftment after HSCT with ANC ≥500/mm3 on three different days
  • Stable calcineurin inhibitor dosage with no changes within 7 days prior to infusion
  • Steroid dosage tapered to less than 0.5 mg/kg/day prednisone (or equivalent) at least 7 days prior to infusion
  • Karnofsky/Lansky score greater than 70
  • Absolute neutrophil count ≥500/µl
  • Hemoglobin ≥8.0 g/dl (can be achieved with transfusion)
  • Platelets ≥20,000/µl (can be achieved with transfusion)
  • Bilirubin ≤2 times upper limit of normal
  • AST and ALT ≤2.5 times upper limit of normal
  • Estimated glomerular filtration rate (GFR) greater than 60 mL/min/1.73 m2
  • Pulse oximetry ≥92% on room air for at least 7 days prior to infusion
  • Age-appropriate mean arterial pressure without vasopressors
  • Negative pregnancy test for females of childbearing potential
  • Use of effective contraception or abstinence for 6 months after treatment for participants of childbearing potential
  • Written informed consent or assent from participant, parent, or guardian
  • Donors aged 2 to 80 years in good health meeting FDA regulations with negative pregnancy test for females of childbearing potential
Not Eligible

You will not qualify if you...

  • Receipt of T cell-targeting biological or immunosuppressive monoclonal antibodies within 28 days prior to infusion
  • Receipt of donor lymphocyte infusion, CAR T cell therapy, or other experimental cellular therapies within 28 days prior to infusion
  • Use of ruxolitinib or other JAK inhibitors within 7 days prior to infusion
  • Uncontrolled or progressing infections or active fever ≥38.1°C within 7 days prior to infusion
  • Positive SARS-CoV-2 RT-PCR test indicating active infection
  • Hypotension below age-appropriate thresholds
  • Pulse pressure greater than 40 mmHg
  • Respiratory rate over 20 breaths per minute
  • Heart rate greater than or equal to 140 beats per minute
  • Uncontrolled hypertension defined by age-specific blood pressure limits
  • Metabolic instability
  • Pediatric participants with modified Ross heart failure Class II or adults with NYHA Class II heart failure
  • Advanced pulmonary disease requiring oxygen or positive pressure ventilation
  • Neurological or psychiatric disorders increasing risk or impairing consent
  • Receipt of checkpoint inhibitors within 3 months prior to infusion
  • Proven or suspected multi-system inflammatory syndrome (MIS)
  • Breastfeeding
  • Receipt of live vaccines within 30 days or any SARS-CoV-2 vaccine within 28 days prior to enrollment
  • Other medical conditions posing safety risks as determined by investigators
  • Anticipated need for blood transfusion within 48 hours of infusion
  • Unwillingness to use effective contraception during the study if applicable
  • Donors with physical or psychological risks or complicated COVID-19 history including MIS or thromboembolic events

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

S

Susan Conway, MD

CONTACT

F

Fahmida Hoq, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

3

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