T cell imaging in kidney transplantation (TIK)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Radboud universitair medisch centrum Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Phenomena and Processes [G] - Immune system processes [G12]

Decision date (initial)

2026-06-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

National Institute of Allergy and Infectious Diseases (NIAID) · ImaginAb

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Characterize the [89Zr]-Df-Crefmirlimab PET signals in kidneys (native/graft), lymph nodes (cervical, hilar, mediastinal), spleen, liver and bone marrow in kidney transplant recipients (rejecting, non-rejecting and T cell depleted) and previously scanned patients without kidney disease. This will give us an idea about the feasibility and potential of CD8+ T cell PET imaging for kidney transplant monitoring.

Secondary objectives 1

1. Investigate whether there is a correlation between the [89Zr]Df-Crefmirlimab PET signal in the transplanted kidney, spleen, bone marrow and lymph nodes of the kidney transplant recipients and the blood immune cell counts and phenotype in the peripheral blood of these patients.

Conditions and MedDRA coding

Renal allograft rejection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients from one of the following categories: 1: kidney transplant recipients without suspicion of rejection (n=3). 2: kidney transplant recipients with biopsy-proven rejection or suspected rejection for which a kidney biopsy is planned (n=3) 3: kidney transplant recipients that received T cell depleting antibodies in the last 3 months prior to the start of the study (n=3)
2. Age 50-80 years old.
3. Written informed consent.
4. For female participants: evidence of post-menopausal status or negative serum pregnancy test and use of effective birth control. Women will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)

Exclusion criteria 9

1. Current infection or infection within 1 month prior to study.
2. Known with chronic liver disease.
3. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons).
4. Inability to undergo PET-CT scanning.
5. Female patients who are pregnant or breastfeeding.
6. Chemotherapy in the past.
7. (Functional) asplenia.
8. Female patients of reproductive potential who are not willing to employ effective birth control from screening to 33 days after the last dose of study drug.
9. Male patients of reproductive potential who are not willing to employ effective birth control from screening to 123 days after the last dose of study drug.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The [89Zr]-Df-Crefmirlimab PET signal in kidneys (native/graft), lymph nodes (cervical, hilair, mediastinal), spleen, liver and bone marrow in patients with and without rejection or T cell depleting therapy.

Secondary endpoints 1

1. In addition to the [89Zr]Df-Crefmirlimab PET/CT, we will also quantify various immune cell subsets, such as CD8+ T cells, in blood by flow cytometry.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Radboud universitair medisch centrum Stichting

Sponsor organisation

Radboud universitair medisch centrum Stichting

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Raphaël Duivenvoorden

Public contact point

Organisation

Radboud universitair medisch centrum Stichting

Contact name

Raphaël Duivenvoorden

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications