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Also known as CAR-Tregs
TX200-TR101 · 1 trial · 2 indications
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
| Arm | Type | Description |
|---|---|---|
| Treatment group | EXPERIMENTAL | Subjects undergo kidney transplant as per planned standard of care and are administered study drug post transplantation. |
| Control group | NO_INTERVENTION | Control group: Subjects undergo kidney transplant as per planned standard of care with no study drug administered. |
| Name | Type | Description |
|---|---|---|
| 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. |
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 Criter...
TX200-TR101 is an investigational cell therapy developed by Sangamo Therapeutics for kidney transplant rejection. It is a chimeric antigen receptor T-regulatory (CAR T-Reg) cell therapy being studied in living donor renal transplant recipients. It is a biologic and has been evaluated in a single Phase 1/2 clinical trial.
TX200-TR101 is being developed for kidney transplant rejection in living donor renal transplant recipients, a population that also includes patients with end stage renal disease. The goal of the program is to evaluate the safety and tolerability of the therapy in this transplant setting.
TX200-TR101 is developed by Sangamo Therapeutics, Inc., which trades under the ticker SGMOQ. Sangamo is the sponsor of the clinical program evaluating the therapy in kidney transplant recipients.
TX200-TR101 is in Phase 1/2 clinical development. It is investigational and has been studied in one completed Phase 1/2 trial. The program has not advanced beyond this early-stage study based on the available development record.
TX200-TR101 has been evaluated in the completed Phase 1/2 trial NCT04817774, titled a safety and tolerability study of chimeric antigen receptor T-Reg cell therapy in living donor renal transplant recipients. The trial enrolled 26 participants across Belgium, the Netherlands, and the United Kingdom, in adults 18 years and older.
The Phase 1/2 trial of TX200-TR101, NCT04817774, was a no-treatment-controlled study and was not randomized or double-blind. It enrolled 26 participants and did not use biomarker-based patient selection. The study is listed as completed.