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At present, the treatment of multiple myeloma (MM) has evolved from traditional chemotherapy to a comprehensive model that includes targeted drugs, immunotherapy, etc. However, the prognosis of recurrent/refractory MM patients remains severe. For patients who are already resistant to multiple major drugs such as proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies, the prognosis is particularly poor. B-cell maturation antigen (BCMA) plays a crucial role in regulating B cell proliferation and survival. BCMA is expressed in various hematological malignancies such as multiple myeloma and has become an important biomarker, promising therapeutic target, and research direction for these diseases.
The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. The core of LNP mRNA technology targeting BCMA is to encapsulate the mRNA encoding specific proteins (such as anti BCMA related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection. The experimental drug WGb 0302 injection is a BCMA based messenger RNA (mRNA) therapeutic drug, formed by loading mRNA encoding BCMA receptor related proteins onto lipid nanoparticles (LNP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WGb-0302 injection, Escalation doses | Experimental |
| |
| WGb-0302 injection, Extended doses | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WGb-0302 injection | Drug | WGb-0303 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of dose limiting toxicity (DLT) | Within 90 days after the initial treatment | |
| Maximum tolerated dose (MTD)or optimal biological dose (OBD) | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Through study completion, an average of 2 years | |
| Progression free survival (PFS) | From date of initial treatment until the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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