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CAR T-cell Therapy

T Cell Therapy for COVID-19 (TONI Trial)

Phase 1

Recruiting

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky/Lansky score >70

Male and female participants of childbearing age must use highly effective birth control measures or practice abstinence

Must not have

Donation of cells would pose a physical or psychological risk to the donor

Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies within 28 days prior to CST infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 45 days of cst infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a coronavirus-specific T cell therapy is safe for people who are immunocompromised and have had a hematopoietic stem cell transplant. The trial will have two parts, one for adults and one for children, testing different doses of the therapy. The goal is to see if the therapy can help prevent SARS-CoV-2 infection.

Who is the study for?

This trial is for immunocompromised patients aged 12-80 who are post allogeneic hematopoietic stem cell transplantation (HSCT). They must be at risk of COVID-19, have stable vital signs, normal organ function tests, and not be pregnant or breastfeeding. Participants should not have active COVID-19 infection or recent vaccinations and must agree to use effective birth control.

What is being tested?

The study is testing the safety of donor-derived coronavirus-specific T cells (CST) in preventing COVID-19 after HSCT. It's an open-label phase I trial with dose escalation to determine safe levels for adults and children in separate arms based on their age.

What are the potential side effects?

Potential side effects may include immune reactions due to infused T cells, such as fever or fatigue. There could also be risks associated with infusion itself like discomfort or infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself and carry out daily activities.

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I am using effective birth control or practicing abstinence.

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I am between 12 and 79 years old.

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I had a stem cell transplant between 28 days and 4 months ago and am at risk for COVID-19.

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I am not pregnant or breastfeeding.

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My bone marrow transplant is successful with stable white blood cell counts.

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I am between 2 and 80 years old.

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My kidney function, measured by Cystatin C, is normal or near normal.

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My blood pressure is normal without needing medication to raise it.

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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Donating cells would be harmful to my health or mental well-being.

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I haven't had any experimental cell therapies like CAR T-cell therapy in the last 28 days.

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I need extra oxygen or a machine to help me breathe due to lung disease.

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I have not had a fever of 38.1°C or higher in the last week.

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I do not have any ongoing serious infections that are getting worse despite treatment.

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I haven't taken ruxolitinib or similar medications in the last 7 days.

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My blood pressure is not controlled and is above the recommended levels for my age.

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I haven't taken any immune system targeting drugs like ATG or Tocilizumab in the last 28 days.

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I haven't had a fever of 38.1°C or higher in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 45 days of cst infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 45 days of cst infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 45 days of cst infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Multi-System Inflammatory Syndrome (MIS)

Incidence of Systemic Inflammatory Response Syndrome (SIRS) or CRS

Incidence of acute Graft Vs Host Disease (aGVHD) grade ≥3

+1 more

Secondary study objectives

Antiviral Activity

COVID-19 antiviral immunity using intracellular ELIspot assays

COVID-19 antiviral immunity using intracellular flow cytometry

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prevention of SARS-CoV-2 infection in immunocompromised pediatric patientsExperimental Treatment1 Intervention

In this dose escalation trial, donor derive coronavirus-specific T cell (CST) (three doses, 1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for pediatric (≥12 years of age and \<18 years) HSCT recipients (Arm B).

Group II: Prevention of SARS-CoV-2 infection in immunocompromised adult patientsExperimental Treatment1 Intervention

In this dose escalation trial, donor derive coronavirus-specific T cell (CST) (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)

0 / 19Eligibility criteria met