Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 monoclonal antibody being developed for kidney transplant rejection. It is intended for patients with end stage renal disease who have received a living donor kidney transplant, with the goal of preventing or reducing the risk of transplant rejection.
TX200-TR101 is being developed by Sangamo Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SGMO. The company is conducting clinical research to evaluate the safety and tolerability of this investigational therapy.
TX200-TR101 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and tolerability in patients.
TX200-TR101 has been studied in one completed Phase 1 clinical trial, identified as NCT04817774. This trial was a safety and tolerability study of chimeric antigen receptor T-reg cell therapy in living donor renal transplant recipients, conducted in Belgium, Netherlands, and the United Kingdom.
TX200-TR101 is a chimeric antigen receptor T-reg cell therapy, as described in the clinical trial NCT04817774. The trial title refers to this therapy, and TX200-TR101 is the drug name used for this investigational cell therapy product.