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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. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.
The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA | Drug | in vivo CAR-T drug based on LNP-mRNA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) and its incidence rate | Within 28 days after the initial treatment | |
| Maximum tolerated dose (MTD) or optimal biological dose (OBD) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 1 month | |
| Disease control rate (DCR) | Through study completion, an average of 2 years | |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
May involve other exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Xinqiao Hospital | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| 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 |