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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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This is a single arm, open-label, single-center, phase 1 study, to determine the safety and efficacy of autologous reinfusion of CAR-T cells targeting BCMA in the treatment of refractory/relapsed multiple myeloma (r/r MM) who get recurrence and progression after previous CAR-T cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T Re-treatment group | Experimental | Patients will be treated with CAR-T cells targeting BCMA (Different epitope with the previous CAR-T cell treatment they had been used) with a escalation approach, 0.5x10^6- 2.0x10^6 CAR-T cells/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T Re-treatment | Drug | Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) or use their mononuclear cells that preserved in the laboratory for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the re-treatment of CAR-T therapy by intravenous injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment related adverse events | assessed by CTCAE v4.0, >= Grade 1 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment | Day 1-30 days after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-myeloma responses | by measuring the changes of aberrant immunoglobulin in serum | Day 1-60 months |
| Anti-myeloma responses | multiple myeloma cells in bone marrow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan-Hong Zhao, MD, PhD | Second Affiliated Hospital of Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710000 | 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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| Day 1-60 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 |