Safety & Tolerability Study of Chimeric Antigen Receptor... | NCT04817774

ID	Type	Description	Link
2019-001730-34	EudraCT Number
2024-512579-11-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2021Actual

Primary Completion Date

Jul 11, 2024Actual

Completion Date

Oct 16, 2025Actual

First Submitted Date

Mar 9, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

May 28, 2025

Results First Submitted that Met QC Criteria

Jun 29, 2026

Results First Posted Date

Jul 2, 2026Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients. TX200-TR101 is a product made from a kidney transplant recipient's own immune cells, which are genetically modified and designed to help the transplant recipient's body accept their donated kidney and prevent their immune system from rejecting it.

Detailed Description

This is a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.The aim is for the CAR-Tregs to recognise the HLA-A2 molecule present on the donated kidney and subsequently induce and maintain immunological tolerance to the organ.

The study requires two arms - transplant recipients who will receive the study treatment TX200-TR101and control participants, who are transplant recipients who will not receive the study treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Subjects undergo kidney transplant as per planned standard of care and are administered study drug post transplantation.	Biological: TX200-TR101
Control group	No Intervention	Control group: Subjects undergo kidney transplant as per planned standard of care with no study drug administered.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TX200-TR101	Biological	TX200-TR101 is an autologous gene therapy medicinal product composed of Treg cells (CD4+/CD45RA+/CD25+/CD127low/neg) that have been ex vivo expanded and transduced with a lentiviral vector encoding for a CAR to recognize HLA-A*02. Treatment will be given via an IV infusion at a pre-defined timepoint several weeks after transplant. Four, single ascending dose cohorts of TX200-TR101 are planned and an additional expansion cohort.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent.
Male or female aged 18 - 70 years.
Diagnosis of End Stage Renal Disease and waiting for a new kidney from an identified live donor.
Subjects who will be single organ recipients (kidney).
Able and willing to use contraception.

Exclusion Criteria:

HLA identical to the donor.
Subjects with prior organ transplant.
Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug.
Positive serology for human immunodeficiency virus (HIV) or syphilis, active or occult hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or other clinically active local or systemic infection.
Subjects who are Epstein-Barr Virus (EBV) seronegative.
Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
Subjects with panel-reactive antibody (PRA) >20% within 6 months prior to enrolment.
Subjects with current or recent donor-specific antibodies.
Use of any experimental medicinal product within 3 months.
Current use of systemic immunosuppressive agents
Significant unstable or poorly controlled acute or chronic diseases (except ESRD), limited life expectancy, clinically relevant central nervous system pathology, history of drug/alcohol abuse or psychiatric disorder or other condition that is not compatible with adequate study follow-up, history of malignancy in the past 5 years and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
Subjects with abnormal laboratory values in the following parameters:
Haemoglobin
Platelets
White blood cells
Aspartate transaminase (AST) and or alanine transaminase (ALT)
Total bilirubin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Women of childbearing potential: negative pregnancy test

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Leuven		Leuven			Belgium
University Medical Center Groningen

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms