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Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | CLL-1 targeting CAR-T treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CLL1 CART cells | Drug | In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE after CAR-T infusion | Incidence of adverse events after CAR-T infusion Data. The records of adverse events (AE) should include: description of AE and all related symptoms, occurrence time, severity, duration, measures taken, final results and outcomes. According to NCI CTC AE 5.0 standard, AE was scored Grade. Safety evaluation indexes include but are not limited to the following contents
| up to 12 months after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| ORR rate | Overall response rate (ORR=CR+CRi) after CAR-T infusion | 1month, 2 months, 3months, 6months ,12months after CAR-T infusion |
| PFS | Progression free survival (PFS) after CAR-T infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Sanbin, Doctor | Contact | (86)13187424131 | Sanbin1011@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.212 Daguan Road, Xishan District | Recruiting | Kunming | Yunnan | 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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|
|
| 1month, 2 months, 3months, 6months ,12months after CAR-T infusion |
| OS | overall survival (OS) after CAR-T infusion | 1month, 2 months, 3months, 6months ,12months after CAR-T infusion |
| Change of CAR Copies | CAR Copies measured by qPCR after CAR-T infusion | Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion |
| Change of CAR-T cell counts | CAR-T cell counts measured by Flow cytometry after CAR-T infusion | Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |