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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients (NCT05141058) is a Phase 1 interventional studying SARS-CoV-2 Infection, sponsored by Children's National Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For SARS-CoV-2 Infection, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 24 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Participant Inclusion Criteria for CST Infusion: 1. For recipient of CSTs derived from an HSCT donor under Arm A: a. Patients aged ≥18 years and \<80 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \<4 months ago who are at risk of SARS-CoV-2 infection. 2. For recipient of CSTs derived from an HSCT donor under Arms B and C: a. Patients aged ≥2 years and \<18 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \<4 months ago who are at risk of SARS-CoV-2 infection. 3. Have evidence of primary engraftment following HSCT (defined by white blood cell count (ANC) at least 500/mm3 for three consecutive measurements on different days, respectively) 4. Participants receiving calcineurin inhibitors for treatment of GVHD, or for other reasons, should not have any dosage changes within 7 days prior to infusion\*\* a. For patients receiving steroids, dosage must have been tapered to \<0.5 mg/kg/day of prednisone (or equivalent) at least 7 days prior to infusion. 5. Karnofsky/Lansky score \>70. 6. ≥2 years to \<80 years of age at enrollment. 7. Absolute neutrophil count (ANC) ≥500/ul. 8. blood count (hemoglobin) at least 8.0g/dl (level can be achieved with transfusion). 9. platelet count at least 20 K/ul (level can be achieved with transfusion)\*. 10. Bilirubin ≤2x upper limit normal. 11. Aspartate transaminase (AST) ≤2.5x upper limit of normal. 12. Alanine transaminase (ALT) ≤2.5x upper limit of normal. 13. Estimated GFR \>60mL/min/1.73m2 (calculated per institutional standards). 14. Pulse oximetry of ≥92% on room air for at least 7 days prior to infusion. 15. Age appropriate mean arterial pressure without the use of vasopressors. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participant Inclusion Criteria for CST Infusion: 1. For recipient of CSTs derived from an HSCT donor under Arm A: a. Patients aged ≥18 years and \<80 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \<4 months ago who are at risk of SARS-CoV-2 infection. 2. For recipient of CSTs derived from an HSCT donor under Arms B and C: a. Patients aged ≥2 years and \<18 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \<4 months ago who are at risk of SARS-CoV-2 infection. 3. Have evidence of primary engraftment following HSCT (defined by ANC ≥500/mm3 for three consecutive measurements on different days, respectively) 4. Participants receiving calcineurin inhibitors for treatment of GVHD, or for other reasons, should not have any dosage changes within 7 days prior to infusion\*\* a. For patients receiving steroids, dosage must have been tapered to \<0.5 mg/kg/day of prednisone (or equivalent) at least 7 days prior to infusion. 5. Karnofsky/Lansky score \>70. 6. ≥2 years to \<80 years of age at enrollment. 7. Absolute neutrophil count (ANC) ≥500/ul. 8. Hemoglobin ≥8.0g/dl (level can be achieved with transfusion). 9. Platelets ≥20 K/ul (level can be achieved with transfusion)\*. 10. Bilirubin ≤2x upper limit normal. 11. Aspartate transaminase (AST) ≤2.5x upper limit of normal. 12. Alanine transaminase (ALT) ≤2.5x upper limit of normal. 13. Estimated GFR \>60mL/min/1.73m2 (calculated per institutional standards). 14. Pulse oximetry of ≥92% on room air for at least 7 days prior to infusion. 15. Age appropriate mean arterial pressure without the use of vasopressors. 16. Negative pregnancy test in female participant of childbearing potential. 17. Male and female participants of childbearing potential must use highly effective birth control measures or practice abstinence for a minimum of 6 months after receiving study therapy 18. Written informed consent and/or signed assent line from participant, parent or guardian. Donor Inclusion Criteria: 1. Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have fulfilled eligibility as per FDA regulations outlined in 21 Code of Federal Regulations (CFR) 1271 subpart C. This includes that donors have been deemed in good health by donor physician based on physical examination and laboratory testing. If a donor has been chosen for the transplant based on urgent medical need that same donor will also be used for CST generation provided that there are no new reasons for ineligibility since the stem cell collection. 2. Donor or guardian of pediatric donor capable of providing informed consent. 3. 2 to 80 years of age. 4. Female donors of childbearing potential must have a negative pregnancy test. Exclusion Criteria: Participants Exclusion Criteria for CST Infusion: 1. Participants receiving biological or immunosuppressive monoclonal antibodies targeting T cells within 28 days prior to CST infusion, including ATG, Alemtuzumab, Basiliximab, Tociluzimab, Brentuximab, or other medications under this category as determined by the investigators. a. If alemtuzumab has been received within 6 weeks prior to CST infusion, plasma levels should be obtained to ensure drug clearance (≤0.16 pg/ml). 2. 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. 3. Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to CST infusion. 4. Participants with uncontrolled or progressing infections or active infections causing fever (temperature ≥38.1°C). Uncontrolled infections are defined as bacterial, fungal, or viral infections (including HIV and Hepatitis B and C) with either clinical signs of worsening despite standard therapy that may be attributed to the uncontrolled infection. Progressing infection is defined as hemodynamic instability, worsening physical signs, or radiographic findings attributable to infection. 1. For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to CST infusion. 2. For fungal infections, participants must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection within 7 days prior to CST infusion. 5. Participants with unexplained fever (temperature ≥38.1°C) within 7 days prior to CST infusion. 6. Participants with evidence of active SARS-CoV-2 infection based on SARS-CoV-2 RT-PCR positivity. 7. Participants with hypotension (mean arterial pressure \<50mmHg in participants \<5 years of age, \<55 mmHg in participants ≥5 and \<14 years of age or \<60 mmHg in participants ≥14 years of age). 8. Participants with pulse pressure \>40 mmHg. 9. Participants with respiratory rate \>20 breaths per minute. 10. Participants with heart rate ≥140 beats per minute. 11. Participants with uncontrolled hypertension as defined by systolic blood pressure \>99th percentile for age (participants \<18 years), and systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg (participants ≥18 years). 12. Participants with metabolic instability. 13. Pediatric participants with modified Ross heart failure Class II disease and adult participants with NYHA Class II disease. 14. Participants with advanced pulmonary disease as defined by requirement for supplemental oxygen or positive pressure ventilation due to pulmonary disease. (This includes participants with active interstitial lung disease (ILD)/pneumonitis, advanced pulmonary disease, a history of ILD/pneumonitis requiring treatment with systemic steroids or a baseline oxygen requirement). 15. Participants with neurological or psychiatric disorders that would, in the opinion of the investigators, place them at increased risk of harm, impact the investigator's abilities to screen for adverse events in the subject, or impair the subject's ability to provide informed consent. 16. Participants receiving checkpoint inhibitors within the previous 3 months prior to CST infusion, including nivolumimab, pembroluzimab, or other related medications. 17. Participants with proven or suspected MIS (in both adults and children) based on the CDC definition and investigator judgement. 18. Participants who are breastfeeding. 19. Participants who have received live vaccines within 30 days, or any SARS-CoV-2 vaccine in the past 28 days prior to enrollment. 20. Participants with any other unrelated medical conditions that would impact the participant's safety in the opinions of the investigators. 21. Participants anticipated to need a blood transfusion within 48 hours of CST infusion. 22. Participants unwilling to utilize effective contraception during the study period (if applicable) Donor Exclusion Criteria: 1. Donation of cells would pose a physical or psychological risk to the donor. 2. Prior or current complicated course of COVID-19, including but not limited to MIS, CRS, or thromboembolic complications based on investigator judgement.

Treatments Being Tested

BIOLOGICAL

Coronavirus-specific T cell (CST)

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).

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Children's National Hospital
Washington D.C., District of Columbia, United States
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Baltimore, Maryland, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05141058), the sponsor (Children's National Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05141058 clinical trial studying?

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 (… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05141058?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05141058?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05141058. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05141058. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.