Cell therapy using thymic Treg cells to manage immune response in COVID-19 and ARDS
Open Phase I/IIa Clinical Trial to Evaluate the Safety and Efficacy of Allogenic Administration of Treg Cells Obtained From Thymic Tissue (thyTreg) to Control The Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome
This study is testing whether a new type of immune cell therapy can help people with severe COVID-19 and ARDS by calming down their overactive immune response.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Drugs / interventions | basiliximab |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06052436 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of allogeneic thymic regulatory T cells (thyTreg) in patients experiencing immune hyperactivation due to COVID-19 and acute respiratory distress syndrome (ARDS). The study employs a sequential parallel group design and aims to determine if these specialized Treg cells can help restore immune balance and reduce excessive inflammation. Participants will receive either 5 million or 10 million thyTreg cells, with the goal of improving clinical outcomes and preventing multi-organ failure associated with severe respiratory conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are hospitalized with acute respiratory failure due to non-cardiogenic causes and exhibit specific inflammatory markers.
Not a fit: Patients who are pregnant, have a high body mass index, or are not expected to survive 48 hours after enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve survival rates and recovery for patients suffering from severe COVID-19 and ARDS.
How similar studies have performed: Preliminary results from related studies using Treg cells indicate feasibility and safety, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient over 18 to 65 years of age 2. Patient Informed and non-opposed to the research by his medical doctor during hospitalization 3. Patient with clinical, radiological, gasometric and immunological criteria defined as: 1. Acute respiratory failure secondary to acute lung injury of noncardiogenic cause 2. Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan) 3. PaO2/FiO2≤ 300 Presence of at least one of the following markers of inflammation: IL6 \> 40 pg/ml or ferritin \>300 ng/ml or CRP \>3 mg/dl or increasing over the last 24 hours Exclusion Criteria: 1. Pregnancy or breast feeding 2. Body mass index \>35 3. Patients not expected to survive 48 hours after enrolment based on clinical assessment 4. Patients with an extracorporeal respiratory support 5. Neutropenia (absolute neutrophil count \<1000/uL) 6. Thrombocytopenia (absolute neutrophil count \<50000/uL) 7. Positive serology for HBV, HCV, or HIV at Screening 8. Life expectancy of less than 6 months due to other pathologies 9. History of significant underlying pulmonary disease requiring oxygen therapy prior to inclusion. 10. Patients with a history of autoimmune diseases 11. Patients with a history of hematopoietic neoplasia or oncology disease 12. Patients with a history of hematopoietic or solid organ transplant 13. Patients with a congenital or induced immunodeficiency 14. Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit 15. Patients received other cell therapy in the last 12 months 16. Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit 17. Patients who have participated or is participating in a clinical research study evaluating COVID-19 or ARDS within 30 days prior to the screening visit
Where this trial is running
Madrid, Madrid
- Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Rafael Correa-Rocha, PhD — Hospital General Universitario Gregorio Marañon
- Study coordinator: Marta Martínez-Bonet, PhD
- Email: marta.mbonet@iisgm.com
- Phone: 34 915866455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.