Kidney TransplantationPhase 1Eight-TregNCT06777719
Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients
A Phase 1 study testing Eight Treg in people with Kidney Transplantation, run by Nantes University Hospital at 1 site in France.
Trial summary
The only curative treatment for end-stage renal disease is through kidney transplantation. Solid organ transplants success had been made possible by the development of Immunosuppressive (IS) drugs. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Eight Treg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2025to 18 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WOCBP must have a negative serum pregnancy test.
- Respects the following conditions:
- Condition 1: number of CD8+ Tregs / ml of blood > 2.096x106 CD8+ Tregs / weight
- Condition 2 (depending on the dose level considered):
- Dose 1: number of CD8+ Tregs / ml of blood > 1.15x104 CD8+ Tregs + 3.18x103 CD8+ Tregs / weight
- Dose 2: number of CD8+ Tregs / ml of blood > 4.6x104 CD8+ Tregs + 3.18x103 CD8+ Tregs / weight
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- Dose 3: number of CD8+ Tregs / ml of blood > 9.22x104 CD8+ Tregs + 3.18x103 CD8+ Tregs / weight
- Pre-Exclusion Criteria:
- Patient has previously received any tissue or organ transplant other than the planned kidney graft.
- Genetically identical to the prospective organ donor at the HLA loci.
- Known contraindication to the protocol-specified treatments / medications or components used in the manufacture of the experimental drug.
- Presence of donor-specific antibodies (DSA) detected prior transplantation determined by Luminex within 3 months or presence of cytotoxic DSA determined by cell-based CDC assay.
- Previous treatment with any desensitisation procedure (with or without IVIg).
- 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).
- ABO incompatibility
- Evidence of significant local or systemic infection on visit 1.
- Malignant or pre-malignant haematological conditions.
- Ongoing treatment with systemic IS drugs at visit 1 (except corticoids < 10 mg).
- Any vaccine (or vaccine recall) dated within 3 months on visit 1 except the SARS Cov2*.
- Participation in another clinical trial during the study or within 28 days prior to the planned study entry and / or exposure to an investigational product during the study or within 28 days prior to the planned study entry (date of signature of the consent collection form).
- Women who are pregnant (or planning to be during the course of the study) or breastfeeding or women with a positive pregnancy test on enrolment (visit 1, screening failure).
- Psychological, familial, sociological or geographical factors that potentially hampering compliance with the study protocol and follow-up visit schedule.
- Any form of drug abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated study personnel.
- Any pro-coagulant disposition, as evidences by a past history of thromboembolic disease or abnormal laboratory coagulation parameters which, in the judgement of the investigator, would place the subject at undue risk.
- Any condition resulting in a substantial reduction in the volume of the pulmonary vasculature or an increase in the pulmonary vascular resistance. Any disease or disease process leading to substantially elevated pulmonary arterial pressure (as evidences by electrocardiography, echocardiography, radiology or cardiac catheterization) or right heart hypertrophy or dysfunction.
- Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates.
- Patients unable to freely give their informed consent (e.g. patients under guardianship, curatorship, protection of justice).
- Patients deprived of their liberty.
Who cannot join
- Human Immunodeficiency Virus (HIV)-positive, Epstein-Barr Virus (EBV)-negative (if donor is EBV positive), HTLV positive, syphilis-positive serology or suffer from chronic viral hepatitis.
- Significant liver disease, defined as persistently elevated Aspartate Transaminase (AST) and / or Alanine Transaminase (ALT) levels > 2 x upper limit of normal range.
- Donor:
- Pre-Inclusion Criteria:
- Willing and able to provide a blood and an urine sample for the immune monitoring.
- Willing to provide personal and medical/biological data for the trial analysis.
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- Signed and dated written informed consent *.
- Aged at least of 18 years the day the consent is signed.
- Affiliated or beneficiary of a social security scheme.
- Speaking and understanding French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
Gilles Pr BLANCHO, 02400087454, gilles.blancho@chu-nantes.fr
Gilles Pr BLANCHO
About this study
Official title: Eight-Treg Study: a Phase I Dose Escalation Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients
The only curative treatment for end-stage renal disease is through kidney transplantation. Solid organ transplants success had been made possible by the development of Immunosuppressive (IS) drugs. However, the long-term survival of transplants is still shortened by the chronic dysfunction of the graft which is not prevented by current IS regimens. Moreover, these IS drugs increase the risk of opportunistic infections and malignancies, and have many non-immune side-effects that hamper their tolerability.
New research strategies are, therefore, developed with the aim of reducing the dependence on conventional pharmacological IS drugs. Regulatory cell therapy is one of these strategies. It consists of expanding specific populations of immune regulatory cells ex vivo into cell-based drugs that can then be infused into transplant recipients, with the goal of inducing graft tolerance.
Read more
This is the framework of this clinical trial. The experimental drug "Eight Treg" being evaluated in this study is an autologous cell therapy product containing CD8+ regulatory T lymphocytes (Tregs) expanded ex vivo during 21 days of cell culture. Team 2 of the Center for Research in Transplantation and Translational Immunology (CR2TI), Nantes University, INSERM, Mixed Research Unit (UMR) 1064, responsible for developing the manufacturing process of the experimental drug "Eight Treg", has demonstrated the feasibility of the expansion of CD8+ Tregs ex vivo and their ability to prevent skin graft rejection and inhibit Graft Versus Host Disease (GVHD) in NOD-Scid-IL-2γ-/- mouse models (NSG)14.
Based on the preclinical experience of CR2TI team 2, which has been working on basic and translational aspects of CD8+ Tregs for 15 years, the present phase I clinical trial aims to assess the safety of increasing doses of the experimental drug "Eight Treg" in 9 recipients of renal transplantation from a living donor. The possibility of manufacturing the experimental drug "Eight Treg" at the required doses, in accordance with the Good Manufacturing Process (GMP), has been assessed in validation runs as specified at the end of the "justification of the study" part of this protocol. This clinical trial will be the first administration of expanded CD8+ Tregs into humans, and it follows previous studies which evaluated the safety of other regulatory cell therapy products, containing expanded CD4+ Tregs and other regulatory cells (autologous tolerogenic dendritic cells performed by Nantes CHU laboratory and clinical services, for example), injected into patients in different contexts (renal transplantation, liver transplantation, GVHD, type 1 diabetes, etc) without causing any significant adverse effect. This study will pave the way for future, broader research on the use of CD8+ Tregs as a possible anti-rejection and tolerance inducer "drug" in transplantation.
- Conditions
- Kidney Transplantation
- Being tested
- Eight Treg
- Keywords
- Kidney transplantation, living donor kidney, immunotherapy, CD8+ T cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eight TregDrug
The experimental drug "Eight Treg" is given to patients with a peripheral IV infusion the day before the graft (cf section "5.1.5. "Infusion of the experimental drug" of this protocol) in addition to the maintenance protocol combining corticosteroids, tacrolimus and MPA which are classically pre-scribed in kidney graft patients from a living donor at the Nantes CHU.
| Study group | Role | What they receive |
|---|---|---|
| Eight -Treg infusion Arm | Experimental | The experimental drug "Eight Treg"is given to patients with a peripheral IV infusion the day before the graft in addition to the maintenance protocol combining corticosteroids, tacrolimus and MPA which are classically pre-scribed in kidney graft patients from a living donor at the Nantes CHU. Receives: Drug: Eight Treg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 3 months post-graft
Measured: 3 months
Occurrence of a dose-limiting toxicity, defined as the occurrence of an AE of grade 3 or higher (with exceptions: see specific section) up to visit 10, at 3 months post-transplantation.
Measured: 3 months
Secondary outcomes (6)
Number of participants with the (absence or low) occurrence of a dose limiting toxicity at 6 and 12 months post-graft
Measured: 12 months
Number of participants with the (no or low stage of) graft inflammation at 3-months post-graft
Measured: 3 months
Number of participants with the (lower) total immunosuppressive burden at one post-transplant year
Measured: 12 months
Number of participants with the (lower) incidence, duration and severity of infections during the first year post-graft compared to historical data from previously reported studies
Measured: 12 months
Biological evaluation of the impact of CD8+ Treg cell therapy on immune response by real time follow-up of blood cell count by flow cytometry (FC) to evaluate and characterize cellular and humoral immune responses towards the graft
Measured: 12 months
Comparison of Tregs profile and clones emerging in the "Eight-Treg" group by scRNAseq and VDJseq compared to reference group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start3 Mar 2025
- Primary completion18 May 2027 (estimated)
- Study completion18 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CR2TI, INSERM, UMR1064
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777719
- Sponsor's protocol ID
- RC24_0033
- Other IDs
- 2024-513771-40-01
- Acronym
- Eight-Treg
- Status last verified
- Apr 2026
- First submitted
- 23 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight-Treg Study: a Phase I Dose Escalation Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06777719
- Acronym / sponsor ID
- Eight-Treg / RC24_0033
- Conditions
- Kidney Transplantation
- Keywords
- Kidney transplantation, living donor kidney, immunotherapy, CD8+ T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- CR2TI, INSERM, UMR1064
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 18 May 2027 (estimated)
- Study completion
- 18 May 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The only curative treatment for end-stage renal disease is through kidney transplantation. Solid organ transplants success had been made possible by the development of Immunosuppressive (IS) drugs. However, the long-term survival of transplants is still shortened by the chronic dysfunction of the graft which is not prevented by current IS regimens. Moreover, these IS drugs increase the risk of opportunistic infections and malignancies, and have many non-immune side-effects that hamper their tolerability.
New research strategies are, therefore, developed with the aim of reducing the dependence on conventional pharmacological IS drugs. Regulatory cell therapy is one of these strategies. It consists of expanding specific populations of immune regulatory cells ex vivo into cell-based drugs that can then be infused into transplant recipients, with the goal of inducing graft tolerance.
This is the framework of this clinical trial. The experimental drug "Eight Treg" being evaluated in this study is an autologous cell therapy product containing CD8+ regulatory T lymphocytes (Tregs) expanded ex vivo during 21 days of cell culture. Team 2 of the Center for Research in Transplantation and Translational Immunology (CR2TI), Nantes University, INSERM, Mixed Research Unit (UMR) 1064, responsible for developing the manufacturing process of the experimental drug "Eight Treg", has demonstrated the feasibility of the expansion of CD8+ Tregs ex vivo and their ability to prevent skin graft rejection and inhibit Graft Versus Host Disease (GVHD) in NOD-Scid-IL-2γ-/- mouse models (NSG)14.
Based on the preclinical experience of CR2TI team 2, which has been working on basic and translational aspects of CD8+ Tregs for 15 years, the present phase I clinical trial aims to assess the safety of increasing doses of the experimental drug "Eight Treg" in 9 recipients of renal transplantation from a living donor. The possibility of manufacturing the experimental drug "Eight Treg" at the required doses, in accordance with the Good Manufacturing Process (GMP), has been assessed in validation runs as specified at the end of the "justification of the study" part of this protocol. This clinical trial will be the first administration of expanded CD8+ Tregs into humans, and it follows previous studies which evaluated the safety of other regulatory cell therapy products, containing expanded CD4+ Tregs and other regulatory cells (autologous tolerogenic dendritic cells performed by Nantes CHU laboratory and clinical services, for example), injected into patients in different contexts (renal transplantation, liver transplantation, GVHD, type 1 diabetes, etc) without causing any significant adverse effect. This study will pave the way for future, broader research on the use of CD8+ Tregs as a possible anti-rejection and tolerance inducer "drug" in transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eight -Treg infusion Arm | Experimental | Drug: Eight TregThe experimental drug "Eight Treg"is given to patients with a peripheral IV infusion the day before the graft in addition to the maintenance protocol combining corticosteroids, tacrolimus and MPA which are classically pre-scribed in kidney graft patients from a living donor at the Nantes CHU. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- WOCBP must have a negative serum pregnancy test.
- Respects the following conditions:
- Patient has previously received any tissue or organ transplant other than the planned kidney graft.
- Genetically identical to the prospective organ donor at the HLA loci.
- Known contraindication to the protocol-specified treatments / medications or components used in the manufacture of the experimental drug.
Key exclusion criteria (10 listed)
- Human Immunodeficiency Virus (HIV)-positive, Epstein-Barr Virus (EBV)-negative (if donor is EBV positive), HTLV positive, syphilis-positive serology or suffer from chronic viral hepatitis.
- Significant liver disease, defined as persistently elevated Aspartate Transaminase (AST) and / or Alanine Transaminase (ALT) levels > 2 x upper limit of normal range.
- Willing and able to provide a blood and an urine sample for the immune monitoring.
- Willing to provide personal and medical/biological data for the trial analysis.
- Signed and dated written informed consent *.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eight TregThe experimental drug "Eight Treg" is given to patients with a peripheral IV infusion the day before the graft (cf section "5.1.5. "Infusion of the experimental drug" of this protocol) in addition to the maintenance protocol combining corticosteroids, tacrolimus and MPA which are classically pre-scribed in kidney graft patients from a living donor at the Nantes CHU. | Drug | Eight -Treg infusion Arm |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 3 months post-graft
Time frame: 3 months
Occurrence of a dose-limiting toxicity, defined as the occurrence of an AE of grade 3 or higher (with exceptions: see specific section) up to visit 10, at 3 months post-transplantation.
Time frame: 3 months
6 secondary outcomes
Number of participants with the (absence or low) occurrence of a dose limiting toxicity at 6 and 12 months post-graft
Time frame: 12 months
Number of participants with the (no or low stage of) graft inflammation at 3-months post-graft
Time frame: 3 months
Number of participants with the (lower) total immunosuppressive burden at one post-transplant year
Time frame: 12 months
Number of participants with the (lower) incidence, duration and severity of infections during the first year post-graft compared to historical data from previously reported studies
Time frame: 12 months
Biological evaluation of the impact of CD8+ Treg cell therapy on immune response by real time follow-up of blood cell count by flow cytometry (FC) to evaluate and characterize cellular and humoral immune responses towards the graft
Time frame: 12 months
Comparison of Tregs profile and clones emerging in the "Eight-Treg" group by scRNAseq and VDJseq compared to reference group
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eight Treg in people with Kidney Transplantation, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilles BLANCHO (0240087454, gilles.blancho@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 3 months post-graft (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.