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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The Second People's Hospital of Huai'an | OTHER |
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This is a prospective,open-label, phase1/2 study to evaluate the safety and efficacy of anti-FLT3 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of FLT3 positive relapsed or refractory acute myeloid leukemia.
The patients will receive infusion of anti-FLT3 CAR T-cells targeting FLT3 to evaluate the safety and efficacy of anti-FLT3 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T infusion | Experimental | FLT3 positive relapsed or refractory acute myeloid leukemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-FLT3 CAR-T | Biological | Single intravenous infusion of anti-FLT3 CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0 x 109/L) or thrombocytopenia (<100 x 109/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, Ph.D | Contact | (0086)51267781856 | xwtang1020@163.com | |
| Lin Yang, Ph.D | Contact | (0086)18896802149 | huimin.meng@persongen.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Tang, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | 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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| PersonGen BioTherapeutics (Suzhou) Co., Ltd. | INDUSTRY |
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| 2 years |
| Event-free survival (EFS) | time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause | 2 years |
| Cumulative incidence of relapse(CIR) | time from the date of achievement of a remission until the date of relapse | 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |