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| Name | Class |
|---|---|
| Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | INDUSTRY |
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CAR technology has been used in T cell therapy and gets great success in treating hematological diseases. Following models of CAR T cells, CAR NK cell therapy has been one hot point. For myeloid malignancies, CD33 is widely expressed. Targeting CD33 surface antigens by CAR NK cells provides an off-the-shelf immune cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antiCD33 CAR NK cells | Experimental | After preconditioning with chemotherapy, the antiCD33 CAR NK cells will be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD33 CAR NK cells | Biological | 6×10^8, 12×10^8, 18×10^8/KG Treatment follows a lymphodepletion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Remission Rate (ORR) | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CRi), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies | 4 weeks after infusion |
| incidence of participants with dose limiting toxicity (DLT) | To characterize the safety, tolerability of Anti-CD33 CAR NK cells | within 4 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | up to 2 years after infusion | |
| Overall Response Rate (ORR) | up to 2 years after infusion | |
| Overall survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi zhang, MD/PhD | Contact | 13808310064 | +86 | zhangxxi@sina.com |
| ruihao huang, MD | Contact | 18984398751 | +86 | 1169731117@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| xi zhang, MD/PhD | Department of Hematology, Xinqiao Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Xinqiao Hospital | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39748428 | Derived | Huang R, Wang X, Yan H, Tan X, Ma Y, Wang M, Han X, Liu J, Gao L, Gao L, Jing G, Zhang C, Wen Q, Zhang X. Safety and efficacy of CD33-targeted CAR-NK cell therapy for relapsed/refractory AML: preclinical evaluation and phase I trial. Exp Hematol Oncol. 2025 Jan 2;14(1):1. doi: 10.1186/s40164-024-00592-6. |
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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 |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Single Group Assignment
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| Fludarabine | Drug | recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline. |
|
| Cytoxan | Drug | recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline. |
|
| up to 2 years after infusion |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |