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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05141253 | Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors | EARLY_PHASE1 | RECRUITING | 24 | — | — | Jan 12, 2022 | Nov 1, 2036 | Apr 27, 2022 | 1 | China |
Type and incidence of dose-limiting toxicity (DLT) by dose group
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
| Arm | Type | Description |
|---|---|---|
| RD133 treatment group | EXPERIMENTAL | Administration of RD133 Three dose groups of 1.0×10\^6 CAR-T/kg, 3.0×10\^6 CAR-T/kg, and 6.0×10\^6 CAR-T/kg RD133 are designed in this study. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT. RD133 will be intravenously infused at least 24 hours after lymphodepletion preconditioning. According to the assigned dose group, the designated dose of RD133 will be infused in a single infusion within 30 minutes on day 0. |
| Name | Type | Description |
|---|---|---|
| RD133 | DRUG | The enhanced MSLN-CAR-T cell design of this study is obtained by co-infecting T cells with two lentiviral vectors. One lentiviral vector expresses CD19-CAR and tEGFR molecular safety switch, and the other lentiviral vector expresses MSLN- CAR and dnTGFβRII receptors. dnTGFβRII receptor without intracellular signal is used to resist the inhibition of T cell function by the immune microenvironment of tumor tissue. In addition, for the safety of CAR-T cell application in vivo, tEGFR is used in the CAR design as a molecular safety switch for CAR-T cells. |
Inclusion Criteria: 1. The subject must personally sign the written informed consent form approved by the ethics committee before the start of the study; 2. 2.≥18 years of age; 3. Have received at least 2 prior standard treatments, and achieved no response to the last-line treatment; 4. \>25% Mesot...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520 / GEH200521 - Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | — | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |