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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07312630 | Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies | EARLY_PHASE1 | RECRUITING | 19 | — | — | Sep 25, 2025 | Dec 12, 2027 | Dec 31, 2025 | 1 | China |
According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
| Arm | Type | Description |
|---|---|---|
| Injection of CD19-Targeted Chimeric Antigen Receptor T Cells | EXPERIMENTAL | A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU. |
| Name | Type | Description |
|---|---|---|
| LV009 Injection Infusion | BIOLOGICAL | A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU. |
Inclusion Criteria: * Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions * Expected survival time exceeds 12 weeks * ECOG performance status 0-2 * Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-posi...