NCT06852625

Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.

Detailed description

The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years. An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry. Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15). * 30 highly sensitized patients will be pre-included in the study. * The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Tolerogenic Dendritic Cells	• Autologous Tolerogenic Dendritic Cells (D+1 to D+3 post-transplantation), ATDC, 1 million ATDC/Kg over a period of 30 minutes (up to 1 hour) will administer between Day 1 and Day 3 after transplantation.

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2025-02-28
• Last updated: 2025-02-28

Locations

7 sites across 1 country: Spain