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The clinical trial was terminated due to a change in sponsor strategy.
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This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLL1/+CD33 CAR-T | Experimental | The target dose range for subjects was set to be 1.00~2.50x10^6/kg CAR-positive T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLL1/+CD33 CAR-T | Biological | CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cytokine level after CLL1/+CD33 CAR-T infusion | Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion. | CAR T cell infusion before and 12 months after infusion |
| The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion. | Track CAR-T cells expansion in patients after infusion by flow cytometry | CAR T cell infusion before and 12 months after infusion |
| The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion. | Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction(qPCR) | CAR T cell infusion before and 12 months after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event. | Up to 12 months after CLL1/+CD33 CAR-T infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Zhang, doctor | Children's Hospital of Fujian Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Children's Hospital | Fuzhou | Fujian | 350005 | 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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| Overall survival | Death from any cause from the beginning of cell transfusion | Up to 12 months after CLL1/+CD33 CAR-T infusion |
| Duration of Overall Response | The time from the start of cell infusion when CR or PR is first achieved to disease progression. | Up to 12 months after CLL1/+CD33 CAR-T infusion |
| MRD negative rate | The rate of MRD negative subjects was determined by flow cytometry. | Up to 12 months after CLL1/+CD33 CAR-T infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |