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| Name | Class |
|---|---|
| Anhui Provincial Hospital | OTHER_GOV |
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This is a clinical study of TAA6 cell injection in the treatment of patients with relapsed / refractory Acute Myeloid Leukemia . The purpose is to evaluate the safety and effectiveness of CD276 targeted autologous chimeric antigen receptor T cells infusion in patients with relapsed / refractory CD276 positive Acute Myeloid Leukemia.(TAA6 cell injection is a T cell targeting CD276 chimeric antigen receptor)
AML is a malignant disease of myeloid hematopoietic stem / progenitor cells and the most common hematological malignancy. It is characterized by abnormal proliferation of primitive and immature myeloid cells in bone marrow and peripheral blood. In recent years, due to the aging of the population, the incidence of AML and MDS has been on the rise. What is also troubling us is that the incidence of treatment-related MDS and AML in children and adolescents with Hodgkin's disease, sarcoma, breast and testicular tumors, lymphoma and other patients who survive after treatment is also gradually increasing. Occupational exposure such as ionizing radiation and benzene and petrochemical are also related to the incidence of AML.
Car t therapy is the most effective and widely used in the treatment of all. B7-H3, also known as cd276, was first discovered in 2001. It is mainly expressed on the cell surface, such as activated dendritic cells, monocytes, T cells, B cells and NK cells. Studies have shown that B7-H3 can stimulate the expansion and killing of T cells, and may selectively stimulate the signal receptor of T cells. It is a promising target for AML immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAA6 cell injection | Experimental | Drug: TAA6 cell injection(Targeting CD276 autologous chimeric antigen receptor T cells) Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells.Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric antigen receptor T cells (car-t) | Other | Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR 3 ORR 3 | 3-month objective response rate | three months after CAR-T cells infusion |
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Inclusion Criteria:
Age 18-70 (including the cut-off value), and the gender was not limited;
The expected survival time ≥ 12 weeks;
ECOG score 0-2;
After the standard treatment, the disease relapsed or progressed, and the researchers judged that there was no other positive effect Standard treatment plan;
The liver and kidney function and cardiopulmonary function meet the following requirements:
Able to understand the trial and have signed the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingbing Wang | Contact | 13856007984 | wangxingbing@ustc.edu.cn | |
| Huimin Meng | Contact | 0551-65728070 | huimin.meng@persongen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xingbing Wang | No.1, Swan Lake Road, new administrative and Cultural District, Hefei City, Anhui Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230000 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |