Could a single infusion of 'Trainer' cells let kidney patients ditch daily pills?
NCT ID NCT06777719
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new cell therapy called Eight Treg in 9 people receiving a kidney from a living donor. The therapy uses the patient's own immune cells, grown in a lab, to help the body accept the new kidney without strong anti-rejection drugs. The main goal is to check safety, but researchers hope it may one day reduce the need for lifelong medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD8+ regulatory T cells (Eight Treg)
- What this could lead to
- If successful, this could reduce the need for lifelong immunosuppressive drugs after kidney transplant, lowering infection and cancer risks.
- What could go wrong
- This is a very early Phase 1 trial with only 9 people, focused on safety. The therapy may not work or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
for kidney transplant recipient: pre-Inclusion Criteria: 1. Man or woman with chronic renal failure requiring kidney transplantation and approved to receive a primary kidney allograft from a living donor. 2. Weight between 50 and 100 kg. 3. Up-to-date vaccination against SARS Cov2 depending on the health situation and the rules in force with last recall done at least 6 to 1 month prior to visit 1. 4. Negative microlymphocytotoxicity (LCT) and flow cytometry crossmatches regardless of HLA compatibility 5. Signed and dated written informed consent \*. 6. Aged at least of 18 years the day the consent is signed. 7. Able to commence the IS regimen at the protocol-specified time point. 8. As a precautionary measure, women of childbearing age should use an effective method of birth control, and male participants should use contraception to avoid partner pregnancy for the duration of the trial. 9. Affiliated or beneficiary of a social security scheme. 10. Speaking and understanding French. Inclusion Criteria: 1. WOCBP must have a negative serum pregnancy test. 2. 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 * Dose 3: number of CD8+ Tregs / ml of blood \> 9.22x104 CD8+ Tregs + 3.18x103 CD8+ Tregs / weight Pre-Exclusion Criteria: 1. Patient has previously received any tissue or organ transplant other than the planned kidney graft. 2. Genetically identical to the prospective organ donor at the HLA loci. 3. Known contraindication to the protocol-specified treatments / medications or components used in the manufacture of the experimental drug. 4. 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. 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. ABO incompatibility 8. Evidence of significant local or systemic infection on visit 1. 9. Malignant or pre-malignant haematological conditions. 10. Ongoing treatment with systemic IS drugs at visit 1 (except corticoids \< 10 mg). 11. Any vaccine (or vaccine recall) dated within 3 months on visit 1 except the SARS Cov2\*. 12. 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). 13. 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). 14. Psychological, familial, sociological or geographical factors that potentially hampering compliance with the study protocol and follow-up visit schedule. 15. 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. 16. 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. 17. 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. 18. Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates. 19. Patients unable to freely give their informed consent (e.g. patients under guardianship, curatorship, protection of justice). 20. Patients deprived of their liberty. Exclusion Criteria: 1. 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. 2. 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: 1. Willing and able to provide a blood and an urine sample for the immune monitoring. 2. Willing to provide personal and medical/biological data for the trial analysis. 3. Signed and dated written informed consent \*. 4. Aged at least of 18 years the day the consent is signed. 5. Affiliated or beneficiary of a social security scheme. 6. Speaking and understanding French.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Nantes
RECRUITINGNantes, 44093, France
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