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Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 1\. Age range of 18-70 years old, gender not limited;

• 2\. Expected survival time exceeds 12 weeks;

• 3\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines

• 4\. There are assessable lesions (applicable only to lymphoma patients);

• 5\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1;

• May involve other inclusion criteria

Locations
Other Locations
China
Department of Hematology, Xinqiao Hospital
RECRUITING
Chongqing
Time Frame
Start Date: 2025-12-20
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 47
Treatments
Experimental: in vivo CAR-T drug based on LNP-mRNA
Sponsors
Leads: Xinqiao Hospital of Chongqing

This content was sourced from clinicaltrials.gov

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