Actively Recruiting
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
Led by Nantes University Hospital · Updated on 2026-04-29
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
C
CR2TI, INSERM, UMR1064
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying kidney transplantation recipients to evaluate a new type of cell therapy called "Eight Treg," which contains regulatory CD8+ T cells expanded outside the body. This phase I clinical trial aims to assess the safety of increasing doses of this experimental drug in patients receiving a kidney from a living donor. The study builds on previous research showing the potential of regulatory cells to promote graft tolerance and reduce reliance on traditional immunosuppressive drugs, which can cause side effects and increase infection risks. Participants receive the "Eight Treg" treatment as an intravenous infusion one day before their kidney transplant surgery. This is given in addition to the standard maintenance immunosuppressive regimen, including corticosteroids, tacrolimus, and MPA, commonly prescribed to kidney transplant patients. The trial will administer escalating doses of the cell therapy to evaluate its safety and feasibility according to good manufacturing practices. This is the first time expanded CD8+ Tregs are administered to humans in this context. During the study, participants are monitored closely for treatment-related adverse events up to three months post-transplant and for dose-limiting toxicities. Additional evaluations include graft inflammation, immune response profiles, infection rates, and overall immunosuppressive burden over one year. Blood samples are analyzed to characterize immune cell responses using flow cytometry and gene sequencing techniques. The study involves follow-up visits up to 12 months after transplantation to assess long-term safety and biological effects of the therapy.
CONDITIONS
Brief Title
Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man or woman with chronic renal failure requiring kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Weight between 50 and 100 kg
- Up-to-date vaccination against SARS Cov2 with last recall at least 1 to 6 months prior to first visit
- Negative microlymphocytotoxicity and flow cytometry crossmatches regardless of HLA compatibility
- Signed and dated written informed consent
- At least 18 years old on consent day
- Able to start immunosuppressive regimen at the specified time
- Women of childbearing age must use effective birth control; male participants must use contraception
- Affiliated or beneficiary of a social security scheme
- Speaking and understanding French
- Women of childbearing potential must have a negative serum pregnancy test
- Must meet required CD8+ Treg cell counts according to dose level
You will not qualify if you...
- Previous tissue or organ transplant other than the planned kidney graft
- Genetically identical to the donor at HLA loci
- Contraindications to protocol treatments or components used in the experimental drug
- Presence of donor-specific antibodies detected within 3 months before transplant
- Previous desensitisation treatment with or without IVIg
- Current or recent malignancy within 5 years, except certain skin cancers
- ABO blood type incompatibility
- Significant local or systemic infection at first visit
- Malignant or pre-malignant blood conditions
- Ongoing systemic immunosuppressive treatment at first visit (except low-dose corticosteroids)
- Vaccination within 3 months prior to first visit except SARS Cov2
- Participation in another clinical trial or exposure to investigational product within 28 days before study
- Pregnant or breastfeeding women or positive pregnancy test at enrollment
- Psychological, family, social, or geographical factors affecting study compliance
- Drug abuse, psychiatric disorder, or other conditions impairing communication
- Pro-coagulant conditions or history of thromboembolic disease
- Pulmonary vascular disease or elevated pulmonary arterial pressure
- Heart defects posing risk of embolism from infused cells
- Unable to give informed consent freely
- Patients deprived of liberty
- HIV positive, EBV negative if donor is EBV positive, HTLV positive, syphilis positive, or chronic viral hepatitis
- Significant liver disease with elevated liver enzymes
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months post-transplant
Participants receive an infusion of the experimental drug "Eight Treg" by peripheral IV the day before kidney graft surgery, in addition to standard maintenance immunosuppressive therapy.
Approximately 10 visits up to 3 months post-transplant
Duration - Up to 12 months post-transplant
Participants are monitored for safety, immune response, and graft outcomes for up to 12 months after treatment.
Visits at 6 and 12 months post-transplant
Trial Site Locations
Total: 1 location
1
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
Research Team
G
Gilles BLANCHO
M
MARION GAUTIER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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