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This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6020 | Experimental | Low, medium and high doses of SYS6020 will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCMA Targeted CAR T-cells | Biological | Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of adverse events (AEs) | Up to approximately 6 months |
| Dose limiting toxicities (DLTs) | Dose limiting toxicities (DLTs) | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Overall response rate (ORR) | Up to approximately 6 months |
| Percentage of subjects who achieved complete response or strict complete response (CR/sCR) | Percentage of subjects who achieved complete response or strict complete response (CR/sCR) |
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Inclusion Criteria:
1. ≥ 18 years of age at the time of signing informed consent;
2. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
3. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);
4. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
6. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.
Exclusion Criteria:
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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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| Up to approximately 6 months |
| Percentage of subjects who achieved very good partial response (VGPR) and higher response rate | Percentage of subjects who achieved very good partial response (VGPR) and higher response rate | Up to approximately 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 |