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This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Multiple myeloma(MM) is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy,objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 20 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-BCMA CAR T cells | Experimental | Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-BCMA CAR T cells | Biological | Transparent colorless or slightly yellow liquid |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety of CAR T is evaluated to determine if CRS occurred | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment | Day 3-Year 2 after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |