SARS-CoV-2 InfectionPhase 1TONINCT05141058
T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
A Phase 1 study testing Coronavirus-specific T cell (CST) in people with SARS-CoV-2 Infection, run by Children's National Research Institute at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- Coronavirus-specific T cell (CST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2021to 15 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant Inclusion Criteria for CST Infusion:
- For recipient of CSTs derived from an HSCT donor under Arm 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.
- For recipient of CSTs derived from an HSCT donor under Arms B and C:
- 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.
- Have evidence of primary engraftment following HSCT (defined by ANC ≥500/mm3 for three consecutive measurements on different days, respectively)
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- Participants receiving calcineurin inhibitors for treatment of GVHD, or for other reasons, should not have any dosage changes within 7 days prior to infusion**
- 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.
- Karnofsky/Lansky score >70.
- ≥2 years to <80 years of age at enrollment.
- Absolute neutrophil count (ANC) ≥500/ul.
- Hemoglobin ≥8.0g/dl (level can be achieved with transfusion).
- Platelets ≥20 K/ul (level can be achieved with transfusion)*.
- Bilirubin ≤2x upper limit normal.
- Aspartate transaminase (AST) ≤2.5x upper limit of normal.
- Alanine transaminase (ALT) ≤2.5x upper limit of normal.
- Estimated GFR >60mL/min/1.73m2 (calculated per institutional standards).
- Pulse oximetry of ≥92% on room air for at least 7 days prior to infusion.
- Age appropriate mean arterial pressure without the use of vasopressors.
- Negative pregnancy test in female participant of childbearing potential.
- 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
- Written informed consent and/or signed assent line from participant, parent or guardian.
- Donor Inclusion Criteria:
- 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.
- Donor or guardian of pediatric donor capable of providing informed consent.
- 2 to 80 years of age.
- Female donors of childbearing potential must have a negative pregnancy test.
Who cannot join
- Participants Exclusion Criteria for CST Infusion:
- 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.
- 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).
- 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.
- Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to CST infusion.
- 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.
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- For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to CST infusion.
- 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.
- Participants with unexplained fever (temperature ≥38.1°C) within 7 days prior to CST infusion.
- Participants with evidence of active SARS-CoV-2 infection based on SARS-CoV-2 RT-PCR positivity.
- 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).
- Participants with pulse pressure >40 mmHg.
- Participants with respiratory rate >20 breaths per minute.
- Participants with heart rate ≥140 beats per minute.
- 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).
- Participants with metabolic instability.
- Pediatric participants with modified Ross heart failure Class II disease and adult participants with NYHA Class II disease.
- 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).
- 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.
- Participants receiving checkpoint inhibitors within the previous 3 months prior to CST infusion, including nivolumimab, pembroluzimab, or other related medications.
- Participants with proven or suspected MIS (in both adults and children) based on the CDC definition and investigator judgement.
- Participants who are breastfeeding.
- Participants who have received live vaccines within 30 days, or any SARS-CoV-2 vaccine in the past 28 days prior to enrollment.
- Participants with any other unrelated medical conditions that would impact the participant's safety in the opinions of the investigators.
- Participants anticipated to need a blood transfusion within 48 hours of CST infusion.
- Participants unwilling to utilize effective contraception during the study period (if applicable)
- Donor Exclusion Criteria:
- Donation of cells would pose a physical or psychological risk to the donor.
- Prior or current complicated course of COVID-19, including but not limited to MIS, CRS, or thromboembolic complications based on investigator judgement.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Baltimore, Maryland, 21287
Tania Jain, MD, 4109557035, tjain2@jhmi.edu
Tania Jain, MD
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Susan Conway, MD, 202-476-5845, sconway@childrensnational.org
Michael Keller, MD, 202-476-5843, mkeller@childrensnational.org
About this study
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.
Read the detailed description
The primary purpose of this phase I study is to assess the safety of administering donor-derived CSTs in immunocompromised participants for prevention of SARS-CoV-2 infection. Related and unrelated donors of participants who are at risk of SARS-CoV-2 infection will be enrolled for screening and production of CSTs from peripheral blood. Following product manufacturing, participants who have undergone HSCT will receive donor-derived CSTs for prevention of SARS-CoV-2 infection.
It is a dose escalation study with separate study arms for adult (Arm A) and pediatric (Arms B and C) recipients of HSCT who are at risk of SARS-CoV-2 infection. Participants who have undergone HSCT and test negative for SARS-CoV-2 infection will be enrolled and receive one dose of CST product derived from their HSCT donor for prophylaxis. Participants aged ≥18 years and <80 years will be enrolled on Arm A, participants who are ≥12 years of age and <18 years of age will be enrolled on Arm B, and participants who are ≥2 years of age and <12 years of age will be enrolled on Arm C.
Investigators will test three doses: 1x107 /m2, 2x107 /m2, and 4x107 /m2. At least 3 adult participants (Arm A) will be enrolled at each dose level before pediatric participants (Arm B) are enrolled. At each dose level, treatment of the first two adult participants enrolled at that dose level will be staggered at least 28 days apart and each will be followed for the 45-day safety monitoring period to assess safety and efficacy of CST product. Once the third adult participant on any given dose level has completed their 45-day safety monitoring period and the safety and efficacy data is reviewed and approved by the FDA, then adult participants can be escalated to the next dose level and pediatric participants can start enrollment at the dose level completed by the adult participants. If participants show evidence of safety and at least 2 of 3 have evidence of antiviral immune reconstitution against SARS-CoV-2, investigators will enroll pediatric participants at that dose level following FDA approval.
Additionally, infusion of pediatric participants enrolled at each dose level will be staggered at least 28 days apart, and all enrolled participants will be followed for 45 days for safety monitoring after CST infusion.
After receiving the CST infusion, participants will be closely monitored to evaluate their health status and the effects of treatment. Follow-up visits will occur frequently and will continue for up to 1 year after the CST infusion. During these visits, study doctors will perform clinical assessments, including medical history and physical examinations. Blood tests will be conducted, such as complete blood count (CBC) and comprehensive metabolic panel (CMP), and research blood samples will also be collected for analysis. These assessments will help monitor safety, toxicity, and treatment effects.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- Coronavirus-specific T cell (CST)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Adults (18 to <80 years) | Experimental | Arm A will include adult participants who are at least 18 years of age but younger than 80 years. Receives: Biological: Coronavirus-specific T cell (CST) |
| Older children (12 to <18 years) | Experimental | Arm B will include adolescent participants who are at least 12 years of age but younger than 18 years. Receives: Biological: Coronavirus-specific T cell (CST) |
| Young children (2 to <12 years) | Experimental | Arm C will include pediatric participants who are at least 2 years of age but younger than 12 years. Receives: Biological: Coronavirus-specific T cell (CST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥3 infusion-related Adverse Events (AEs)
Number of patients with grade ≥3 infusion-related AEs at 45 days of following CST infusion.
Measured: Within 45 days of CST infusion
Incidence of acute Graft Vs Host Disease (aGVHD) grade ≥3
Number of patients with aGVHD grade ≥3 within 45 days of CST infusion.
Measured: Within 45 days of CST infusion
Incidence of Systemic Inflammatory Response Syndrome (SIRS) or CRS
Number of patients with systemic Inflammatory Response Syndrome (SIRS) or CRS
Measured: Within 45 days of CST infusion
Incidence of Multi-System Inflammatory Syndrome (MIS)
Number of patients with MIS
Measured: Within 45 days of CST infusion
Secondary outcomes (4)
COVID-19 antiviral immunity using intracellular flow cytometry
Participant serum and PBMCs will be monitored for COVID-19 virus specific T cell activity at 45 days following CST infusion by phenotypic and functional studies including ELIspot with appropriate viral specific peptide mixtures and available HLA-restricted epitope peptides, intracellular cytokine staining, serum cytokine profiling and/or other assays as they become available for immune profiling purposes
Measured: At 45 days following CST infusion
COVID-19 antiviral immunity using intracellular ELIspot assays
Participant serum and PBMCs will be monitored for COVID-19 virus specific T cell activity at 45 days following CST infusion by phenotypic and functional studies including ELIspot with appropriate viral specific peptide mixtures and available HLA-restricted epitope peptides, intracellular cytokine staining, serum cytokine profiling and/or other assays as they become available for immune profiling purposes
Measured: At 45 days following CST infusion
Persistence of infused CSTs
Persistence of infused T cells will be monitored using deep sequencing to track the TCRB repertoire in the participant peripheral blood
Measured: Within 12 months
Antiviral Activity
Antiviral activity will be assessed by measurement of SARS-CoV-2 viral load by screening RT-PCR from oral/salivary samples or from respiratory samples for any participant who develops a positive SARS-CoV-2 RT-PCR post CST infusion
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Oct 2021
- Primary completion1 Nov 2028 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Conway, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141058
- Sponsor's protocol ID
- TONI
- Acronym
- TONI
- Status last verified
- Mar 2026
- First submitted
- 10 Nov 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT05141058
- Acronym / sponsor ID
- TONI / TONI
- Conditions
- SARS-CoV-2 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary purpose of this phase I study is to assess the safety of administering donor-derived CSTs in immunocompromised participants for prevention of SARS-CoV-2 infection. Related and unrelated donors of participants who are at risk of SARS-CoV-2 infection will be enrolled for screening and production of CSTs from peripheral blood. Following product manufacturing, participants who have undergone HSCT will receive donor-derived CSTs for prevention of SARS-CoV-2 infection.
It is a dose escalation study with separate study arms for adult (Arm A) and pediatric (Arms B and C) recipients of HSCT who are at risk of SARS-CoV-2 infection. Participants who have undergone HSCT and test negative for SARS-CoV-2 infection will be enrolled and receive one dose of CST product derived from their HSCT donor for prophylaxis. Participants aged ≥18 years and <80 years will be enrolled on Arm A, participants who are ≥12 years of age and <18 years of age will be enrolled on Arm B, and participants who are ≥2 years of age and <12 years of age will be enrolled on Arm C.
Investigators will test three doses: 1x107 /m2, 2x107 /m2, and 4x107 /m2. At least 3 adult participants (Arm A) will be enrolled at each dose level before pediatric participants (Arm B) are enrolled. At each dose level, treatment of the first two adult participants enrolled at that dose level will be staggered at least 28 days apart and each will be followed for the 45-day safety monitoring period to assess safety and efficacy of CST product. Once the third adult participant on any given dose level has completed their 45-day safety monitoring period and the safety and efficacy data is reviewed and approved by the FDA, then adult participants can be escalated to the next dose level and pediatric participants can start enrollment at the dose level completed by the adult participants. If participants show evidence of safety and at least 2 of 3 have evidence of antiviral immune reconstitution against SARS-CoV-2, investigators will enroll pediatric participants at that dose level following FDA approval.
Additionally, infusion of pediatric participants enrolled at each dose level will be staggered at least 28 days apart, and all enrolled participants will be followed for 45 days for safety monitoring after CST infusion.
After receiving the CST infusion, participants will be closely monitored to evaluate their health status and the effects of treatment. Follow-up visits will occur frequently and will continue for up to 1 year after the CST infusion. During these visits, study doctors will perform clinical assessments, including medical history and physical examinations. Blood tests will be conducted, such as complete blood count (CBC) and comprehensive metabolic panel (CMP), and research blood samples will also be collected for analysis. These assessments will help monitor safety, toxicity, and treatment effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults (18 to <80 years) | Experimental | Biological: Coronavirus-specific T cell (CST)Arm A will include adult participants who are at least 18 years of age but younger than 80 years. |
| Older children (12 to <18 years) | Experimental | Biological: Coronavirus-specific T cell (CST)Arm B will include adolescent participants who are at least 12 years of age but younger than 18 years. |
| Young children (2 to <12 years) | Experimental | Biological: Coronavirus-specific T cell (CST)Arm C will include pediatric participants who are at least 2 years of age but younger than 12 years. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (27 listed)
- For recipient of CSTs derived from an HSCT donor under Arm A:
- For recipient of CSTs derived from an HSCT donor under Arms B and C:
- Have evidence of primary engraftment following HSCT (defined by ANC ≥500/mm3 for three consecutive measurements on different days, respectively)
- Participants receiving calcineurin inhibitors for treatment of GVHD, or for other reasons, should not have any dosage changes within 7 days prior to infusion**
- Karnofsky/Lansky score >70.
Key exclusion criteria (29 listed)
- 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.
- 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.
- Participants who have received ruxolitinib or other JAK inhibitors within 7 days prior to CST infusion.
- 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.
- Participants with unexplained fever (temperature ≥38.1°C) within 7 days prior to CST infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Biological | Adults (18 to <80 years), Older children (12 to <18 years), Young children (2 to <12 years) |
Primary outcome
Incidence of grade ≥3 infusion-related Adverse Events (AEs)
Time frame: Within 45 days of CST infusion
Number of patients with grade ≥3 infusion-related AEs at 45 days of following CST infusion.
Incidence of acute Graft Vs Host Disease (aGVHD) grade ≥3
Time frame: Within 45 days of CST infusion
Number of patients with aGVHD grade ≥3 within 45 days of CST infusion.
Incidence of Systemic Inflammatory Response Syndrome (SIRS) or CRS
Time frame: Within 45 days of CST infusion
Number of patients with systemic Inflammatory Response Syndrome (SIRS) or CRS
Incidence of Multi-System Inflammatory Syndrome (MIS)
Time frame: Within 45 days of CST infusion
Number of patients with MIS
4 secondary outcomes
COVID-19 antiviral immunity using intracellular flow cytometry
Time frame: At 45 days following CST infusion
COVID-19 antiviral immunity using intracellular ELIspot assays
Time frame: At 45 days following CST infusion
Persistence of infused CSTs
Time frame: Within 12 months
Antiviral Activity
Time frame: Within 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Coronavirus-specific T cell (CST) in people with SARS-CoV-2 Infection, run by Children's National Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Conway, MD (202-476-5845, sconway@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥3 infusion-related Adverse Events (AEs) (time frame: Within 45 days of CST infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.