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Recruiting NCT07349849

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

Early Phase I Interventional B-cell Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: in vivo CAR-T drug based on LNP-mRNA.
Who it may be relevant to
Registry conditions: B-cell Malignancies. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug in vivo CAR-T drug based on LNP-mRNA
    in vivo CAR-T drug based on LNP-mRNA

Primary outcome measures

  • Dose limiting toxicity (DLT) and its incidence rate [Time frame: Within 28 days after the initial treatment]
  • Maximum tolerated dose (MTD) or optimal biological dose (OBD) [Time frame: 3 months]
Secondary outcome measures (3)
  • Objective response rate (ORR) [Time frame: 1 month]
  • Disease control rate (DCR) [Time frame: Through study completion, an average of 2 years]
  • Progression free survival (PFS) [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Hematology, Xinqiao Hospital — Chongqing

Identifiers

NCT: NCT07349849 · in vivo CAR-T of CD19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗