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It did not reach the expected results of clinical trial
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| Name | Class |
|---|---|
| Hangzhou Qihan Biotech Co., Ltd. | INDUSTRY |
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This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).
The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QN-023a | Experimental | QN-023a in adult subjects with r/r AML |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QN-023a | Drug | NK cell therapy |
| |
| Cyclophosphamid |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 28 Days from first dose of QN-023a | |
| The incidence of subjects with Dose Limiting Toxicities within each dose level cohort | 28 Days from first dose of QN-023a |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) | Up to approximately 2 years after last dose of QN-023a | |
| Relapse-free survival (RFS) of participants | Up to approximately 2 years after last dose of QN-023a | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality | 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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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Drug |
Lympho-conditioning Agent |
|
| Fludarabine | Drug | Lympho-conditioning Agent |
|
| Cytarabine | Drug | Lympho-conditioning Agent |
|
| Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood |
The PK of QN-023a in peripheral blood will be reported as the relative percentage of product (QN-023a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
| Up to approximately 2 years after last dose of QN-023a |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |