NCT06777719: Eight-Treg

Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients

Recruiting now Phase 1 Last updated 16 January 2025

What this trial tests

Phase 1 trial testing Eight Treg in Kidney Transplantation in 9 participants. Currently enrolling.

Timeline

3 March 2025

Primary endpoint
15 April 2027

18 May 2027

Quick facts

Lead sponsor	Nantes University Hospital
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	3 March 2025
Primary completion	15 April 2027
Estimated completion	18 May 2027
Sites	1 location across France

Drugs / interventions tested

• Eight Treg — full drug profile →

Conditions studied

• Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 99, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tolerance Induction Strategies in Organ Transplantation: Current Status and Future Perspectives.
   Blein T, Ayas N, Charbonnier S, Gil A, et al · · 2025 · cited 2× · PMID 41127478 · DOI 10.3389/ti.2025.14958
2. Regulatory T cell therapies: biological foundations, engineering strategies, and clinical translation.
   Plaisse C, Bézie S, Guillonneau C. · · 2026 · PMID 42079605 · DOI 10.3389/fimmu.2026.1797186
3. Regulatory T cell therapy in solid organ transplantation: clinical applications and laboratory monitoring strategies.
   Nam M. · · 2025 · PMID 40936404 · DOI 10.4285/ctr.25.0040