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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07002112 | The LVIVO-TaVec100 Product in the Treatment of Relapsed/Refractory B-cell Malignancies | PHASE1 | RECRUITING | 30 | — | — | May 23, 2025 | Jun 30, 2029 | Aug 12, 2025 | 6 | China |
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
CAR positive T cells and CAR transgene percentage of in peripheral blood after LVIVO-TaVec100 infusion.
CAR positive T cells and CAR transgene percentage of in bone marrow after LVIVO-TaVec100 infusion.
RP2D established through 3+3 design and the DLTs occurring following LVIVO-TaVec100 infusion
| Arm | Type | Description |
|---|---|---|
| LVIVO-TaVec100 product | EXPERIMENTAL | Each subject will be given a single-dose LVIVO-TaVec100 product infusion at each dose level. |
| Name | Type | Description |
|---|---|---|
| LVIVO-TaVec100 product | BIOLOGICAL | Prior to infusion of the LVIVO-TaVec100 product, subjects will receive bridging therapy if needed. |
Inclusion Criteria: 1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's di...