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Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.
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 CD19 is to encapsulate the mRNA encoding specific proteins in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
The experimental drug WGb-0301 injection is a CD19 based messenger RNA (mRNA) therapeutic mRNA drug, formed by loading mRNA onto lipid nanoparticles (LNP). WGb-0301 injection has demonstrated efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell malignancies, bringing better clinical benefits to more patients with B-cell malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WGb-0301 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WGb-0301 injection | Drug | WGb-0301 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) and its incidence rate | Within 90 days after the initial treatment | |
| Maximum tolerated dose (MTD) or optimal biological dose (OBD) | Through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Through study completion, an average of 2 year | |
| Disease control rate (DCR) | Through study completion, an average of 2 year | |
| Duration of response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| From the date of the first PR/CR to the date of the first confirmation of progress or death for any reason |
| Progression free survival (PFS) | From the date of initial treatment until the first confirmation of progression or death for any reason |