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)
THYTECH2
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
3 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2023
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2023
CompletedFirst Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 3, 2025
January 1, 2025
4.5 years
September 12, 2023
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Incidence of infusion-related adverse events (safety) by type, frequency, severity, and causality
24 months
Secondary Outcomes (16)
Length of intensive care unit stay
24 months
Oxygenation improvement as assessed using PaO2/FiO2 and/or SaO2/FiO2
24 months
Change in clinical status as assessed using Sequential Organ Failure Assessment Score
24 months
Change in clinical status as assessed using Acute Physiology and Chronic Health disease Classification System (APACHE) III
24 months
Change in clinical status as assessed using Barthel score
24 months
- +11 more secondary outcomes
Study Arms (4)
Phase A: 5.000.000 thyTreg /kg
EXPERIMENTALAllogeneic thyTreg 5.000.000
Phase A: standard of care
NO INTERVENTIONStandard of care
Phase B: 10.000.000 thyTreg /kg
EXPERIMENTALAllogeneic thyTreg 10.000.000
Phase B: standard of care
NO INTERVENTIONStandard of care
Interventions
Treg lymphocytic cells, differentiated, allogeneic, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Treg lymphocytic cells, differentiated, allogeneic, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
Eligibility Criteria
You may qualify if:
- Patient over 18 to 65 years of age
- Patient Informed and non-opposed to the research by his medical doctor during hospitalization
- Patient with clinical, radiological, gasometric and immunological criteria defined as:
- Acute respiratory failure secondary to acute lung injury of noncardiogenic cause
- Pulmonary abnormalities compatible with bilateral alveoloinsterstitial infiltrates by chest imaging (radiograph or scan)
- 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
You may not qualify if:
- Pregnancy or breast feeding
- Body mass index \>35
- Patients not expected to survive 48 hours after enrolment based on clinical assessment
- Patients with an extracorporeal respiratory support
- Neutropenia (absolute neutrophil count \<1000/uL)
- Thrombocytopenia (absolute neutrophil count \<50000/uL)
- Positive serology for HBV, HCV, or HIV at Screening
- Life expectancy of less than 6 months due to other pathologies
- Patients with a history of autoimmune diseases
- Patients with a history of hematopoietic neoplasia or oncology disease
- Patients with a history of hematopoietic or solid organ transplant
- Patients with a congenital or induced immunodeficiency
- Patients received thymoglobulin, basiliximab or any anti-T-cell therapies within 6 moths prior to the screening visit
- Patients received other cell therapy in the last 12 months
- Patients received intravenous immunoglobulin (IVIg) within 5 moths prior to the screening visit
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Correa-Rocha, PhD
Hospital General Universitario Gregorio Marañon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 25, 2023
Study Start
June 27, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 3, 2025
Record last verified: 2025-01