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New treatment option for SARS-CoV-2 Infection
Official title T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
ClinicalTrials.gov ID: NCT05141058
What this study is testing
What is Coronavirus-specific T cell (CST)?
Coronavirus-specific T cell (CST) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sars-cov-2 infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 80
You may be able to join if
- Participant for CST Infusion:
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- Participants who have received donor lymphocyte infusion (DLI), chimeric antigen receptor T cell infusion, or other experimental cellular therapies...
- 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...
- For bacterial infections, participants must be receiving definitive therapy and have no signs of progressing infection within 7 days prior to CST...
See the full eligibility criteria
Who can join
- Participant for CST Infusion:
- 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...
- 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...
- 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\ \ a. For patients receiving steroids, dosage must have been...
- 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
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.