Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.
Within each dose group, the next subject may be dosed after the previous subject has completed at least 14 days of safety observation. Following the assessment of dose-limiting toxicity (DLT) within 28 days after the last subject in each dose group completed a single dose, and upon approval by the Safety Review Committee (SRC) based on clinical safety data to proceed to the next dose group, enrollment and treatment for the next dose group may commence. If one DLT occurs among the first three subjects in a dose group, three additional subjects must be added to that group (bringing the total to six subjects for DLT assessment): If no DLT occurs in the 3 additional subjects, dose escalation continues. If 1 DLT occurs in the 3 additional subjects, dose escalation is halted. If >1 DLT occurs in the 3 additional subjects, dose escalation is halted, and the dose must be reduced by one level to continue enrolling 3 subjects for DLT assessment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TEAE | According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | From the start of infusion of the study drug to 3 months after drug infusion |
| Measure | Description | Time Frame |
|---|---|---|
| (Tmax) | Time to peak concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection | Within 28 days after the transfusion and within 90 days after the transfusion |
| (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingbing Wang, Doctor | Contact | +86-13856007984 | wangxingbing@ustc.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PersonGen.Anke Cellular Therapeutice Co., Ltd. | Recruiting | Hefei | Anhui | 230088 | China |
Because the patent rights have not yet been determined.
Not provided
Not provided
Not provided
Not provided
Not provided
LV009 Injection
Not provided
Not provided
Not provided
Not provided
Maximum concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection
| Within 28 days after the transfusion and within 90 days after the transfusion |
| AUC | Area under the curve of CD19 CAR-T expansion in peripheral blood 28 days after administration of LV009 injection | Within 28 days after administration of LV009 injection |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided