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Clinical Trials in China / NCT07349849
Recruiting Early Phase 1

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

NCT07349849 · tracked via the Priya Life Science China tracker
Sponsor
Xinqiao Hospital of Chongqing
Phase
Early Phase 1
Started
2025-12-20
Last updated
2026-01-20

Condition(s) studied

B-cell Malignancies

Investigational drug(s) / intervention(s)

in vivo CAR-T drug based on LNP-mRNA

in vivo CAR-T drug based on LNP-mRNA: in vivo CAR-T drug based on LNP-mRNA

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 1\. Accompanied by other uncontrolled malignant tumors; * 2\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy; * 3\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection; * 4\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases; * 5\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial. May involve other exclusion criteria

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Department of Hematology, Xinqiao Hospital Chongqing Chongqing Municipality Recruiting

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Other trials for the same condition

Evaluation of SYS6005 in Patients With Advanced Malignant Tumor Recruiting
JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies Recruiting
A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies Recruiting
A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib Active, not recruiting
A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07349849 on ClinicalTrials.gov ↗ ← All trials in China