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| Name | Class |
|---|---|
| Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to infuse BCMA CAR-NK cells(Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells) to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-BCMA CAR-NK Cells | Experimental | After preconditioning with chemotherapy, the Anti-BCMA CAR-NK Cells will be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-BCMA CAR-NK Cells | Biological | 1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Remission Rate (ORR) | Response assessment per International Myeloma Working Group (IMWG) criteria | 2 monthes after infusion |
| Incidence of dose limiting toxicity (DLTs) | To characterize the safety, tolerability of Anti-BCMA CAR-NK Cells | within 2 monthes after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Response assessment per International Myeloma Working Group (IMWG) criteria | up to 24 months |
| Duration of Response (DOR) | Response assessment per International Myeloma Working Group (IMWG) criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xi zhang, PhD/MD | Contact | 13808310064 | +86 | zhangxxi@sina.com |
| ruihao huang, MD | Contact | 18984398751 | +86 | 1169731117@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| xi zhang, PhD/MD | 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 |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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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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Anti-BCMA CAR-NK Cells
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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 24 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |