The ONE Study nTreg Trial (ONEnTreg13) (ONEnTreg13)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02371434|
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immunosuppressive Treatment of Living-donor Renal Transplantation||Biological: autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)||Phase 1 Phase 2|
The ONE Study aims to explore the feasibility, safety and efficacy of regulatory cell therapies as adjunct immunosuppressive treatments in the context of living-donor renal transplantation.The clinical trial presented here (ONEnTreg13) will test autologous, polyclonally expanded CD4+CD25+FoxP3+ nTregs as a somatic cell-based medicinal product.
The objective of this study is to determine whether administration of nTregs to recipients of living-donor kidney transplants is safe and able to polarize the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation - nTregs Trial|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
Experimental: Treatment arm
Patients in ONEnTreg13 will be treated with four immunosuppressive agents, all of which are classified as an Investigational Medicinal Products (IMPs):
Biological: autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)
autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10^6, 1 x 10^6, and 2.5-3 x 10^6 cells/kg body weight in cohorts of three patients each.
- Incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of organ transplantation [ Time Frame: 60 weeks ]
- Incidence of infectious complications associated with cell administration. [ Time Frame: 60 weeks ]
- Incidence of embolic pulmonary complications and other embolic events. [ Time Frame: 60 weeks ]
- Incidence of immune responses resulting in anaphylactic reactions, cardiovascular compromise or other acute organ failure. [ Time Frame: 60 weeks ]
- Biochemical disturbances associated with the cell infusion. [ Time Frame: 60 weeks ]
- Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially, CMV, EBV and polyoma virus. [ Time Frame: 60 weeks ]
- Over-suppression of the immune system assessed by the incidence of neoplasia. [ Time Frame: 60 weeks ]
- Prevention of acute rejection will be secondarily assessed by measuring [ Time Frame: 60 weeks ]i) time to first acute rejection episode ii) severity of acute rejection episodes based on response to treatment and histological scoring iii) the level of total immunosuppression drugs at the final trial visit.
- Incidence of patients treated for subclinical acute rejection on the basis of histopathological findings [ Time Frame: 60 weeks ]
- Prevention of chronic graft dysfunction (chronic rejection or IF/TA) will be assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures. [ Time Frame: 60 weeks ]
- Incidence of post-transplant dialysis, inclusion on the transplant waiting list or retransplantation following graft loss through rejection (acute or chronic). [ Time Frame: 60 weeks ]
- Avoidance of drug-related complications by immunosuppressant reduction will be assessed by the incidence of reported adverse drug reactions. [ Time Frame: 60 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371434
|Charité University Medicine, Dept. of Nephrology and Internal Intensive Care|
|Berlin, Germany, 13353|