Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04817774 | Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients | PHASE1 | ACTIVE NOT_RECRUITING | 26 | — | — | Mar 17, 2021 | Oct 29, 2025 | Feb 10, 2025 | 5 | Belgium, Netherlands +1 |
Safety and tolerability of TX200-TR101 infusion evaluated by 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 and Transplant donors | NO_INTERVENTION | Control group: Subjects undergo kidney transplant as per planned standard of care with no study drug administered. Transplant donors: Transplant donors for each subject in the treatment and control groups. |
| 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...