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New treatment option for Kidney Transplantation
Official title Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06777719
What this study is testing
What is Eight Treg?
Eight Treg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- for kidney transplant recipient: pre-
- 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 depending on the health situation and the rules in force with last recall done at least 6 to 1 month prior...
- Negative microlymphocytotoxicity (LCT) and flow cytometry crossmatches regardless of HLA compatibility
You likely can't join if
- 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...
- 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 /...
See the full eligibility criteria
Who can join
- for kidney transplant recipient: pre-
- 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 depending on the health situation and the rules in force with last recall done at least 6 to 1 month prior to visit 1.
- Negative microlymphocytotoxicity (LCT) and flow cytometry crossmatches regardless of HLA compatibility
- Signed and dated written informed consent \ .
- Aged at least of 18 years the day the consent is signed.
- Able to commence the IS regimen at the protocol-specified time point.
- 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.
- Affiliated or beneficiary of a social security scheme.
- Speaking and understanding French.
- 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
- Dose 3: number of CD8+ Tregs / ml of blood \> 9.22x104 CD8+ Tregs + 3.18x103 CD8+ Tregs / weight Pre-
What rules you out
- 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...
- 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...
- 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. Exclusion Criteria:
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.