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| Name | Class |
|---|---|
| The Pregene (ShenZhen) Biotechnology Company, Ltd. | INDUSTRY |
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The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition 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-tumor response of BCMA CAR-T | Experimental | Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days. Drug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 25-30mg/m2/day IV for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | number of participants with adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of the BCMA CAR+ T cells | determine duration of in vivo survival of BCMA CAR-T cells | 1 year |
| anti-tumor responses of BCMA CAR-T cells | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongping Song | Contact | +86-13521186987 | ph200811@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongping Song | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 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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| Cyclophosphamide |
| Drug |
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days |
|
| BCMA CAR-T | Biological | BCMA CAR-T cells will be administered after completion of the chemotherapy. |
|
| 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 |