Table 1:
ongoing clinical trials adopting regulatory T-cell therapy in solid organ transplantation (search date September 15, 2022)
| Study ID | Phase | Age | Title | Product | Dose | Status | Location |
|---|---|---|---|---|---|---|---|
| Renal transplantation—endogenous Treg expansion | |||||||
| NCT02417870 | I/II | 18-75 (adult, older adult) | Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation | Low-dose recombinant IL-2 (proleukin) | — | Terminated (June 2021) |
Brigham and Women`s Hospital, Boston, US |
| Renal transplantation—adoptive Treg therapy | |||||||
| NCT02088931 | I | 18-50 (adult) |
Treg Adoptive Therapy for Subclinical Inflammation in Kidney Transplantation (TASK) | CD4 + CD127lo/-CD25 + polyclonally expanded Tregs | 3.2 × 108 | Completed (July 2022) |
University of California, San Francisco, US |
| NCT02091232 | I | >18 (adult, older adult) | Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study) | Tregs (recipient) stimulated with donor PBMCs and belatacept | 4-9 × 108 | Completed (Nov 2021) |
Massachusetts General Hospital, Boston, US |
| NCT04817774 | I/II | 18-70 (adult, older adult) | Safety and Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients | CD4 + CD45RA + CD25 + CD127low/- HLA-A*02 specific CAR Tregs | — | Recruiting (Dec 2021) |
University Hospitals Leuven Leuven, Belgium (and 3 other centers) |
| NCT03943238 | I | 18-65 (adult, older adult) | TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation | Autologous polyclonally expanded Tregs | starting at 25 × 106/kg | Recruiting (May 2022) |
Stanford University Palo Alto, Northwestern University Chicago, US |
| NCT03284242 | n/a | 18-65 (adult, older adult) | A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients | Autologous polyclonally expanded Tregs | n/a | Recruiting (May 2022) |
University of Kentucky Medical Center Lexington, Kentucky, US |
| NCT02711826 | I/II | >18 (adult, older adult) | Treg Therapy in Subclinical Inflammation in Kidney Transplantation | Autologous polyclonally expanded Tregs | 5.5 ± 4.5 × 108 | Recruiting (March 2022) |
University of California at San Francisco, US (and 5 other centers) |
| NCT02145325 | I | 18-65 (adult, older adult) | Trial of Adoptive Immunotherapy With TRACT to Prevent Rejection in Living Donor Kidney Transplant Recipients | Autologous polyclonal expanded CD4 + CD25 + nTregs | 0.5-5 × 106 | Completed (Oct 2019) |
Northwestern University Comprehensive Transplant Center Chicago, Illinois, US |
| NCT03867617 | I/II | >18 (adult, older adult) | Cell Therapy for Immunomodulation in Kidney Transplantation | Autologous polyclonally expanded CD4 + CD127lo/- CD25 + CD45RA Tregs | 0.3-1.5 × 107 | Recruiting (Sep 2019) |
Medical University of Vienna, Vienna, Austria |
| NCT01446484 | I/II | 1-18 (child) | Treatment of Children With Kidney Transplants by Injection of CD4 + CD25 + FoxP3 + T Cells to Prevent Organ Rejection | Autologous CD4 + CD25 + CD127low FoxP3 + Tregs | 2 × 108 | Unknown (Nov 2011) |
Russian state Medical University, Moscow, Russian Federation |
| NCT02371434 | I/II | 18-65 (adult, older adult) | The ONE Study nTreg Trial (ONEnTreg13) | Autologous polyclonally expanded CD4 + CD25 + FoxP3 + nTregs | 0.5-3 × 106 | Completed (Feb 2020) |
Charité University Medicine, Berlin, Germany |
| NCT02244801 | I | 18-70 (adult, older adult) | Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study) | Donor alloantigen reactive Tregs (darTregs) | 3 × 108; 9 × 108 | Completed (Oct 2018) |
University of California San Francisco, US |
| NCT02129881 | I/II | >18 (adult, older adult) | The ONE Study UK Treg Trial | Autologous polyclonally expanded Tregs | 1-10 × 106/kg | Completed (Jan 2019) |
Guy’s Hospital London, UK |
| ISRCTN 11038572 |
II | >18 (adult, older adult) | TWO study: cell therapy trial in renal transplantation | Autologous polyclonally expanded Tregs | 5-10 × 106/kg | Recruiting (June 2022) |
Oxford Transplant Centre, Churchill Hospital, Oxford, UK |
| Liver transplantation—endogenous Treg expansion | |||||||
| NCT02739412 | II | 18-65 (adult, older adult) | Efficacy of Low Dose, SubQ Interleukin-2 (IL-2) to Expand Endogenous Regulatory T-Cells in Liver Transplant Recipients | Low-dose recombinant IL-2 (proleukin) | 0.30 MIU per meter squared body surface area; for 4 weeks | Active, not recruiting (May 2021) |
Beth Israel Deaconess Medical Center Boston, Massachusetts, US |
| NCT02949492 | IV | 18-50 (adult) |
Low-dose IL-2 for Treg Expansion and Tolerance (LITE) | Low-dose recombinant IL-2 (proleukin) | — | Terminated (Aug 2019) |
Kings Collage Hospital London, UK |
| Liver transplantation—adoptive cell therapy | |||||||
| NCT01624077 | I | 10-60 (child, adult) | Safety Study of Using Regulatory T Cells Induce Liver Transplantation Tolerance | Autologous polyclonally TGF-β induced CD4 + CD25 + CD127- Tregs | 1 × 106/kg | Unknown (Feb 2015) |
Nanjing Medical University Nanjing, Jiangsu, China |
| NCT03654040 | I/II | 18-70 (adult, older adult) |
Liver Transplantation With Tregs at UCSF | Autologous expanded donor alloantigen reactive Tregs (arTregs) | 30-90 × 106 total Treg cells | Recruiting (Aug 2021) |
University of California, San Francisco San Francisco, California, US |
| NCT03577431 | I/II | 18-70 (adult, older adult) |
Liver Transplantation With Tregs at MGH | Autologous expanded donor alloantigen reactive CD4 + CD25 + CD127- Treg cells (arTregs) | 2.5-125 × 106 | Recruiting (Nov 2021) |
Massachusetts General Hospital: Transplantation Boston, Massachusetts, United States |
| NCT02474199 | I/II | 18-70 (adult, older adult) |
Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (ARTEMIS) | Autologous donor alloantigen reactive Tregs (darTregs) | 3-5 × 108 | Completed (Feb 2021) | University of California at San Francisco San Francisco, US Northwestern University Comprehensive Transplant Ctr Chicago, US Mayo Clinic in Rochester Rochester, US |
| NCT02188719 | I | 21-70 (adult, older adult) | Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (deLTa) | Autologous donor alloantigen reactive Tregs (darTregs) | 2.5-96 × 107 | Terminated (Sep 2020) - has results |
University of California at San Francisco San Francisco, US Northwestern University Comprehensive Transplant Ctr Chicago, US Mayo Clinic in Rochester Rochester, US |
| NCT02166177 | I/II | 18-70 (adult, older adult) | Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients (ThRIL) | Autologous polyclonally expanded Tregs | 0.5-1; 3-4.5 × 106/kg | Completed (Jan 2019) |
Kings College Hospital London, UK |
| UMIN-000015789 | I/II | 18-65 (adult, older adult) | Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation | Donor-reactive Treg-enriched cell product | 0.23-6.37 × 106 Tregs/kg | Recruiting (until July 2012) Data published 2016 [136] |
Hokkaidou University Graduate School of Medicine, Japan |
| NCT05234190 | I/II | 18-70 (adult, older adult) | Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients (LIBERATE) | Autologous CAR Tregs targeting HLA-A2 (HLA-A2 CAR-Treg) | — | Recruiting (Feb 2022) |
Cambridge University Hospitals NHS Foundation Trust Cambridge, UK Royal Free London NHS Foundation Trust London, UK King’s College Hospital NHS Foundation Trust London, UK |