Clinical trial NCT06852625: Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients
Official title: Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Kidney Transplant Rejection
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Side effects of ATDC cell product in highly sensitized patients who received a kidney from a deceased donor.
timeFrame: at day 1 and day 3
Secondary outcomes:
measure: Rate of infectious disease that required hospitalization at 6 and 12 months.
timeFrame: at 6 months and 12 months.
measure: To evaluate incidence of biopsy proven acute rejection episodes in patients treated with ATDC as adjunctive therapy to SOC
timeFrame: at 3 and 12months after transplantation.
measure: To evaluate renal function up to 1 year after transplantation
timeFrame: at 3, 6 and 12 months after transplantation
measure: To evaluate renal function up to 1 year after transplantation
timeFrame: at 3, 6 and 12 months after transplantation
measure: To evaluate patient survival
timeFrame: at 12 months after transplantation
measure: To evaluate graft survival
timeFrame: at 12 months after transplantation
measure: To characterize the immunophenotype status.
timeFrame: 24 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundació Puigvert
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: