Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal… (NCT04817774) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
Belgium, Netherlands, United Kingdom26 participantsStarted 2021-03-17
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 tha…