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

NCT ID: NCT06852625

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-03-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Autologous Tolerogenic Dendritic Cells

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Fundació Puigvert

Barcelona, Barcelona, Spain

Hospital Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Barcelona, Spain

Hospital Universitari Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Countries

Spain

Central Contacts

Fritz Diekmann, Dr

Role: CONTACT

Phone: +34932775444

Email: fdiekman@clinic.cat

Maria Joyera

Role: CONTACT

Phone: +34932775400

Email: joyera@recerca.clinic.cat

Facility Contacts

Anna Vila Santandreu

Role: primary

Marta Crespo Barrio

Role: primary

Carme Facundo

Role: primary

Francesc Josep Moreso Mateos

Role: primary

Fritz Diekmann

Role: primary

Edoardo Melilli

Role: primary

Alex Gutiérrez Dalmau

Role: primary

Other Identifiers

2024-519978-39-00

Identifier Type: -

Identifier Source: org_study_id