NCT06052436 Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Control the Immune Hyperactivation Associated With COVID-19 and/or Acute Respiratory Distress Syndrome (THYTECH2)
| NCT ID | NCT06052436 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hospital General Universitario Gregorio Marañon |
| Condition | Systemic Inflammatory Response Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-06-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2023-06-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators developed a GMP protocol to isolate Treg cells from thymic tissue (thyTreg). The thyTreg cells are being evaluated in a Phase I/II clinical trial to evaluate the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children (NCT04924491), with preliminary results indicating the feasibility and safety of the therapy. In addition, thyTreg cells have shown low immunogenicity in the pre-clinical setting, indicating that allogeneic use of these thyTreg cells (allo-thyTreg) would have a low risk of adverse effects. These thyTreg cells could inhibit an excessive inflammation in SARS-CoV-2 infection, or ameliorate the immunological affection underlying Acute respiratory distress syndrome, improving life-threatening manifestations, restoring immune balance, and protecting affected tissues. This clinical trial is an open-label Sequential Parallel Group Phase I/II study to evaluate the safety and efficacy of allogeneic thymus derived Tregs (thyTreg) (thyTreg) in controlling the immune dysregulation associated with SARS-CoV-2 infection and/or Acute Respiratory Distress Syndrome.
Eligibility 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
Contact & Investigator
Rafael Correa-Rocha, PhD
PRINCIPAL INVESTIGATOR
Hospital General Universitario Gregorio Marañon
Frequently Asked Questions
Who can join the NCT06052436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Inflammatory Response Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06052436 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06052436 currently recruiting?
Yes, NCT06052436 is actively recruiting participants. Contact the research team at marta.mbonet@iisgm.com for enrollment information.
Where is the NCT06052436 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06052436 clinical trial?
NCT06052436 is sponsored by Hospital General Universitario Gregorio Marañon. The principal investigator is Rafael Correa-Rocha, PhD at Hospital General Universitario Gregorio Marañon. The trial plans to enroll 24 participants.