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This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.
This study is a single-arm, open-label, prospective clinical trial. It targets patients with relapsed/refractory acute myeloid leukemia (AML), planning to enroll 10 cases. The study will follow up and observe data related to adverse reactions and treatment efficacy after medication, aiming to evaluate the safety and efficacy of sequential therapy with two types of CAR-T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD123+CLL-1 CAR-T sequential infusion with CD7 CAR-T and bridging to allo-HSCT | Experimental | Treat with CD123+CLL-1 dual-target CAR-T (JY017), then sequentially infuse CD7-targeted CAR-T (JY008) for patients not achieving MRD negativity, perform allo-HSCT based on patient conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic | Biological | For patients with refractory and relapsed AML, CD123+CLL-1 dual-target CAR-T cells (JY017) are used for treatment. Then, for patients who cannot achieve the minimum residual negative, CD7-targeted CAR-T cells (JY008) are sequentially infused. Finally, allogeneic hematopoietic stem cell transplantation is performed based on patient conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor and record adverse events | From CAR - T cell infusion to 2 years later. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | From CAR - T cell infusion to 2 years later . |
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Inclusion Criteria:
Patients must meet all of the following criteria:
Exclusion Criteria:
Any of the following conditions will not be eligible for enrolment in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| erlie Jiang | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn |
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|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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