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| Name | Class |
|---|---|
| Yake Biotechnology Ltd. | INDUSTRY |
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A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis and other diseases may only show local pathological damage or systemic lesions. If they are not diagnosed and treated in time or poorly controlled, they will progress as the course of the disease progresses. Risk of disability or even death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POEMS Syndrome | Experimental |
| |
| Amyloidosis | Experimental |
| |
| Autoimmune Hemolytic Anemia | Experimental |
| |
| Vasculitis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19/BCMA CAR T-cells | Biological | Each subject receive CD19/BCMA CAR T-cells by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion |
| Incidence of treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events [Safety and Tolerability] | Up to 2 years after CD19/BCMA targeted CAR T-cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Titer of auto-antibody Titer of auto-antibody titer of auto-antibody | In peripheral blood and bone marrow | Up to 2 years after CD19/BCMA targeted CAR T-cells infusion |
| Overall response rate (ORR) |
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Inclusion Criteria:
1. Diagnosed with POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis, and the curative effect of conventional hormones, radiotherapy and chemotherapy, protease inhibitors is not good and (or) no effective treatment means.
2. After glucocorticoids, cyclophosphamide or methotrexate treatments there are still relapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.
3. Estimated survival time> 12 weeks; 4. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 5. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria:
Subjects with any of the following exclusion criteria were not eligible for this trial:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Huang, PhD | Contact | +8613605714822 | hehuangyu@126.com | |
| Yongxian Hu, PhD | Contact | +8615957162012 | huyongxian2000@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| He Huang, PhD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of medical college of zhejiang university | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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|
Proportion of subjects with complete or partial remission
| Up to 2 years after CD19/BCMA targeted CAR T-cells infusion |
| Best overall response, BOR | Assessment of ORR at ≤3 month | At ≤3 month |
| Overall survival (OS) | The time from the cell reinfusion to death due to any cause | From CD19/BCMA CAR-T infusion to death,up to 2 years |
| Duration of remission, DOR | The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause | 2 years post CD19/BCMA CAR-T cells infusion |
| ID | Term |
|---|---|
| D016878 | POEMS Syndrome |
| D000686 | Amyloidosis |
| D000744 | Anemia, Hemolytic, Autoimmune |
| D014657 | Vasculitis |
| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D001327 | Autoimmune Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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