Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07349849

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

B-cell Malignancies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of Hematology, Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Location status: Recruiting

Location contact

Xi Zhang, MD phD

CONTACT

[email protected]

13808310064 ext. +86

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

in vivo CAR-T drug based on LNP-mRNA

Drug

in vivo CAR-T drug based on LNP-mRNA

Primary outcomes

  1. Dose limiting toxicity (DLT) and its incidence rate

    Time frame: Within 28 days after the initial treatment

  2. Maximum tolerated dose (MTD) or optimal biological dose (OBD)

    Time frame: 3 months

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: 1 month

  2. Disease control rate (DCR)

    Time frame: Through study completion, an average of 2 years

  3. 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

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.