Status:
ACTIVE_NOT_RECRUITING
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
Lead Sponsor:
Sangamo Therapeutics
Conditions:
Kidney Transplant Rejection
End Stage Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 fr...
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 ki...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04817774
Start Date
March 17 2021
End Date
October 29 2025
Last Update
February 10 2025
Active Locations (5)
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1
University Hospitals Leuven
Leuven, Belgium
2
University Medical Center Groningen
Groningen, Netherlands
3
Leiden University Medical Centre
Leiden, Netherlands, 2333 ZA
4
Erasmus MC, University Medical Center
Rotterdam, Netherlands, 3015 CN