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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 19 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 and severity of Treatment-Emergent Adverse Events[Safety and Tolerability] | Up to approximately 2 years after last dose of QN-023a | |
| Incidence of dose adjustment or discontinuation due to NK cell toxicities | Up to approximately 2 years after last dose of QN-023a | |
| Incidence of subjects with Dose Limiting Toxicities within each dose level cohort | 28 Days from first dose of QN-023a | |
| Determine the maximum tolerated dose (MTD) and RP2D | 28 Days from first dose of QN-023a |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate(ORR) of QN-023a in r/r AML | Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator. | Up to approximately 2 years after last dose of QN-023a |
| Relapse-free survival (RFS) of QN-023a in r/r AML |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, PhD | Contact | 86-13605714822 | hehuangyu@126.com | |
| Yongxian Hu, PhD | Contact | 86-15957162012 | huyongxian2000@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Recruiting | Hangzhou | Zhejiang | 310003 | 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 |
| D005047 | Etoposide |
| 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 |
|
| VP-16 | Drug | Lympho-conditioning Agent |
|
| Up to approximately 2 years after last dose of QN-023a |
| Time to Response (TTR) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a |
| Event-free survival (EFS) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a |
| Overall Survival (OS) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a |
| 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 |
| Evaluate the immunogenicity features of QN-023a | The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured. | 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 |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |