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Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the treatment of AML. The investigators start the Phase I study aimed to treat recurred post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.
Allo-HSCT is increasingly being used for AML, however, leukemia relapse remain a main problem for decades.Recently the investigators have witnessed great progresses in cancer therapy with chimeric antigen receptors modified T cells(CAR-T), especially for B-cell malignance. preclinical data about anti-CD123 CART have shown raised serious safety concerns of human anti-CD123 CAR-T for severe impairment of normal hematopoiesis in NSG mice.Patients with AML recurred after allo-HSCT have a dismal prognosis.The investigators developed donor-derived CART to target CD123 for the treatment of AML. The investigators start the Phase I study aimed to recurred post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells | Experimental | Patients will receive a full dose CART infusion at day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells | Biological | a single dose of CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells will be infusion after preconditioning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03 | 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| CART cells persistence in vivo | 15 years | |
| CAR123-specific antibody level | 15 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu Chen, M.D., Ph.D. | Contact | +86-010-6694-7108 | chenhu217@aliyun.cn | |
| Bin Zhang, M.D., Ph.D. | Contact | +86-010-6694-7125 | zb307ctc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hu Chen, M.D., Ph.D. | Affiliated Hospital to Academy of Military Medical Sciences, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengtai District | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| D007951 | Leukemia, Myeloid |
| D012008 | Recurrence |
| D009370 | Neoplasms by Histologic Type |
| D020969 | Disease Attributes |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
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|
| 15 years |
| Disease response(CR, CRi) | 15 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |