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

NCT06852625 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 2024-519978-39-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of infectious disease that required hospitalization at 6 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

  at 3 and 12months after transplantation.

• To evaluate renal function up to 1 year after transplantation

  at 3, 6 and 12 months after transplantation

• To evaluate renal function up to 1 year after transplantation

  at 3, 6 and 12 months after transplantation

• To evaluate patient survival

  at 12 months after transplantation

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Autologous Tolerogenic Dendritic Cells BIOLOGICAL

• 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with active TB.
• Patients on the waiting list multiple organ transplants.
• 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.
• HIV-positive subjects.
• Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
• Subjects with active CMV or EBV infection as defined by positive PCR.
• Subjects with a known history of previous myocardial infarction within one year of screening.
• Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
• Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
• Pregnant and lactating women.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (7)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Fundació Puigvert

Barcelona, Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Central Study Contacts

Fritz Diekmann, Dr

CONTACT

+34932775444; fdiekman@clinic.cat

Maria Joyera

CONTACT

+34932775400; joyera@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)