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

January 15, 2026 updated by: Xi Zhang, MD, Xinqiao Hospital of Chongqing

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

47

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Recruiting
        • Department of Hematology, Xinqiao Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: in vivo CAR-T drug based on LNP-mRNA
Drug: in vivo CAR-T drug based on LNP-mRNA
in vivo CAR-T drug based on LNP-mRNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose limiting toxicity (DLT) and its incidence rate
Time Frame: Within 28 days after the initial treatment
Within 28 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: 1 month
1 month
Disease control rate (DCR)
Time Frame: Through study completion, an average of 2 years
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinqiao Hospital of Chongqing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • in vivo CAR-T of CD19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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