Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Soochow University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Drug | Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation |
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose-limiting toxicity | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety results | Number of adverse events | Up to 2 years |
| PK | The maximum concentration (Cmax) | Up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaowen tang | Contact | 13913538266 | xwtang1020@163.com | |
| huimin meng | Contact | 18896802149 | huimin.meng@persongen.com.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliared Hospital Of SOOCHOW University | Recruiting | Suzhou | Jiangsu | 215006 | China |
Not provided
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PD | Absolute value of CD7 Positive Cells in peripheral blood at each time point | Up to 2 years |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |