A clinical study in living-related kidney transplant patients aims to assess nTregs cell therapy as a treatment to prevent kidney transplant rejection.

The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Natural regulatory T-cells (nTregs) Trial. - The ONE Study nTregs trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001294-24-DE

Enrollment

Registered

2014-04-24

Start date

2014-11-18

Completion date

Unknown

Last updated

2021-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney allograft rejection following living-donor renal transplantation. MedDRA version: 16.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865

Interventions

Product Name: Natural regulatory T-cells (nTregs) Product Code: nTregs_BCRT Pharmaceutical Form: Infusion Trade Name: -Solu-Decortin® H -Decortin® H Pharmaceutical Form: Injection Trade Name: CellCe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A prospective kidney transplant recipient is eligible for enrolment into the study if all of the following inclusion criteria apply:- 1. Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor 2. Aged at least 18 years 3. Able to commence the immunosuppressive regimen at the protocol-specified time point 4. Willing and able to participate in The ONE Study IM and HEC subprojects 5. Able to provide signed and dated written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patient has previously received any tissue or organ transplant 2. Known contraindication to the protocol-specified treatments / medications 3. Genetically identical to the prospective organ donor at the HLA loci (0-0-0 mismatch) 4. PRA grade > 40% within 6 months prior to enrolment 5. Previous treatment with any desensitisation procedure (with or without IVIg) 6. Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin) 7. Evidence of significant local or systemic infection 8. HIV-positive, EBV-negative or suffering chronic viral hepatitis 9. Significant liver disease, defined as persistently elevated AST and/or ALT levels > 2 x ULN (Upper Limit of Normal range) 10. Malignant or pre-malignant haematological conditions 11. Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives 12. Any condition which, in the judgement of the Investigator, would place the subject at undue risk 13. On-going treatment with systemic immunosuppressive drugs at study entry 14. Participation in another clinical trial during the study or within 28 days prior to planned study entry 15. Female patients of child-bearing potential with a positive pregnancy test at enrolment 16. Female patients who are breast-feeding 17. All female patients of child-bearing potential* UNLESS: a. The patient is willing to maintain a highly effective method of birth control** for the duration of the study b. The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the Investigator) 18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule. 19. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel 20. Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 objective of The ONE Study nTregs Trial is to determine whether administration of nTregs to the recipients of living-donor kidney transplants combined with standard triple immunosuppressive therapy (Prednisolone, Mycophenolate Mofetil and Tacrolimus) is safe and able to polarise the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.;Secondary Objective: Not applicable;Primary end point(s): The primary clinical endpoint is the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of transplantation. The guideline for BCAR is acute graft dysfunction combined with histological evidence of acute rejection. Histopathological grading of biopsy material will be performed by a nominated Central Pathologist according to Banff criteria. This will allow the assessment of BCAR to be standardised across the entire ONE Study. The primary safety endpoint regarding Treg cell administration will be evaluated by the following:- • incidence of infectious complications associated with cell administration • incidence of embolic pulmonary complications and other embolic events • incidence of immune responses resulting in anaphylactoid reactions, cardiovascular compromise or other acute organ failure • biochemical disturbances associated with the cell infusion • Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially CMV, EBV and polyoma virus • Over-suppression of the immune system assessed by the incidence of neoplasia.;Timepoint(s) of evaluation of this end point: Incidences of BCAR occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.	—

Measure

Time frame

Main Objective: 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 objective of The ONE Study nTregs Trial is to determine whether administration of nTregs to the recipients of living-donor kidney transplants combined with standard triple immunosuppressive therapy (Prednisolone, Mycophenolate Mofetil and Tacrolimus) is safe and able to polarise the immunological response of the recipient away from graft rejection and towards graft acceptance, allowing a reduction in the doses of pharmacological maintenance immunosuppression.;Secondary Objective: Not applicable;Primary end point(s): The primary clinical endpoint is the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks of transplantation. The guideline for BCAR is acute graft dysfunction combined with histological evidence of acute rejection. Histopathological grading of biopsy material will be performed by a nominated Central Pathologist according to Banff criteria. This will allow the assessment of BCAR to be standardised across the entire ONE Study. The primary safety endpoint regarding Treg cell administration will be evaluated by the following:- • incidence of infectious complications associated with cell administration • incidence of embolic pulmonary complications and other embolic events • incidence of immune responses resulting in anaphylactoid reactions, cardiovascular compromise or other acute organ failure • biochemical disturbances associated with the cell infusion • Over-suppression of the immune system assessed by the incidence of opportunistic infections, especially CMV, EBV and polyoma virus • Over-suppression of the immune system assessed by the incidence of neoplasia.;Timepoint(s) of evaluation of this end point: Incidences of BCAR occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary clinical endpoints include:- time to first acute rejection episode; severity of acute rejection episodes based on response to treatment and histological scoring; total immunosuppressive burden at the final trial visit; incidence of post-transplant dialysis; return to the transplant waiting list or re-transplantation following graft loss due to rejection (acute or chronic); incidence of adverse drug reactions.;Timepoint(s) of evaluation of this end point: Secondary endpoints occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.	—

Measure

Time frame

Secondary end point(s): Secondary clinical endpoints include:- time to first acute rejection episode; severity of acute rejection episodes based on response to treatment and histological scoring; total immunosuppressive burden at the final trial visit; incidence of post-transplant dialysis; return to the transplant waiting list or re-transplantation following graft loss due to rejection (acute or chronic); incidence of adverse drug reactions.;Timepoint(s) of evaluation of this end point: Secondary endpoints occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis.

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Countries

Germany

Contacts

Public ContactPrincipal Investigator

Charité - Universitätsmedizin Berlin

petra.reinke@charite.de+4930450653 490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026