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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Biological: Autologous Tolerogenic Dendritic Cells

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fritz Diekmann, Dr; Phone Number: +34932775444; Email: fdiekman@clinic.cat
• Study Contact Backup: Name: Maria Joyera; Phone Number: +34932775400; Email: joyera@recerca.clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
    • Contact: Marta Crespo Barrio; Phone Number: +34932483689; Email: mcrespo@psmar.cat
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
    • Contact: Francesc Josep Moreso Mateos; Phone Number: +34932746000; Email: francescjosep.moreso@vallhebron.cat
  • Barcelona, Spain, 08025
    • Fundacio Puigvert
    • Contact: Carme Facundo; Phone Number: +34934169700; Email: cfacundo@fundacio-puigvert.es
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
    • Contact: Fritz Diekmann; Phone Number: +34932275444; Email: fdiekman@clinic.cat
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
    • Contact: Alex Gutiérrez Dalmau; Phone Number: +34976765500; Email: alexgutierrezd@gmail.com
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
      • Contact: Anna Vila Santandreu; Phone Number: +34934978898; Email: annavilas.germanstrias@gencat.cat
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari Bellvitge
      • Contact: Edoardo Melilli; Phone Number: +34932607385; Email: emelilli@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
3. Adequate venous access and absence of contraindications for leukoapheresis.
4. Women of childbearing age must take contraceptive measures.
5. Must have given written informed consent

Exclusion Criteria:

1. Subjects with active TB.
2. Patients on the waiting list multiple organ transplants.
3. A significantly abnormal general serum screening lab result defined as WBC<3.0x103/ml, Hgb<8.0 g/dL, platelet count <100x103/ml, SGOT>3x upper limit.
4. HIV-positive subjects.
5. Subjects who test positive for HBV infection [positive HBVsAg or HBVeAg/DNA] or HCV infection [RNA+].
6. Subjects with active CMV or EBV infection as defined by positive PCR.
7. Subjects with a known history of previous myocardial infarction within one year of screening.
8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
9. Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
10. Pregnant and lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; 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 receive study treatment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.	Proportion of patients with toxicity/side effects during and after administration.	at day 1 and day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of infectious disease that required hospitalization at 6 and 12 months.	Proportion of patients with severe or serious infections at 6 months and 12 months.	at 6 months and 12 months.
To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC	Incidence of BPAR at 3 and 12months after transplantation.	at 3 and 12months after transplantation.
To evaluate renal function up to 1 year after transplantation	Renal function at 3, 6 and 12 months after transplantation as assessed by estimated glomerular filtration rate (eGFR)	at 3, 6 and 12 months after transplantation
To evaluate renal function up to 1 year after transplantation	Renal function at 3, 6 and 12 months after transplantation as assessed by serum/plasma creatinine levels	at 3, 6 and 12 months after transplantation
To evaluate patient survival	Patient survival at 12 months after transplantation	at 12 months after transplantation
To evaluate graft survival	Graft survival at 12 months after transplantation	at 12 months after transplantation
To characterize the immunophenotype status.	Define the different cell subtypes in circulating cells, as well as the functionality of T and B cells using ELISpot and Fluorospot techniques	24 months

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-519978-39-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No