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| Name | Class |
|---|---|
| Hrain Biotechnology Co., Ltd. | INDUSTRY |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shanghai Changzheng Hospital | OTHER |
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The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
Primary Objectives
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-BCMA CAR-T | Experimental | Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-BCMA CAR-T cells | Biological | Retroviral vector-transduced autologous T cells to express anti-BCMA CAR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | 8 weeks |
| Duration of CAR-positive T cells in circulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Province of TCM | Recruiting | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192741 | Derived | Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16. |
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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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| Fludarabine | Drug | dose: 25mg/m2/d |
|
| Cyclophosphamide | Drug | Dose: 40mg/kg |
|
Duration of CAR-positive T cells in circulation |
| 6 months |
| Total number of CAR-positive T cells infiltrated into lymphoma tissue | Total number of CAR-positive T cells infiltrated into lymphoma tissue | 6 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 |