Actively Recruiting
Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies
Led by Xinqiao Hospital of Chongqing · Updated on 2026-01-20
47
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an mRNA therapeutic drug targeting CD19 for the treatment of malignant hematological tumors mainly derived from adult B cells, including acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). Although existing treatments have improved survival rates, relapsed or refractory cases remain challenging. The study explores CD19, a key target in B-cell malignancies, using lipid nanoparticle (LNP) mRNA technology that has been developed and widely applied in areas such as COVID-19 vaccines and cancer therapies. The investigational treatment involves an in vivo CAR-T drug based on LNP-mRNA, which encapsulates mRNA encoding specific proteins related to anti-CD19 activity. This drug is delivered to the body intravenously or intramuscularly. The study is conducted as an early phase 1 trial, focusing on dose-limiting toxicity, maximum tolerated dose, and optimal biological dose assessments within specified timeframes after treatment. Participants aged 18 to 70 years with CD19-positive B-cell lymphoma or lymphocytic leukemia who have no standard treatment options will be involved. The study includes monitoring of dose safety, response rates, disease control, and progression-free survival over periods ranging from 1 month up to 2 years. Physical fitness and lesion assessments will be conducted, and participants will be closely followed for treatment effects and safety outcomes throughout the study duration.
CONDITIONS
Brief Title
Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age range of 18-70 years old, any gender
- Expected survival time exceeds 12 weeks
- Diagnosed with CD19-positive B-cell lymphoma or lymphocytic leukemia without standard treatment options recommended
- Presence of assessable lesions (for lymphoma patients only)
- Eastern Cancer Collaboration Group (ECOG) physical fitness status score of 0 or 1
You will not qualify if you...
- Presence of other uncontrolled malignant tumors
- Previous receipt of chimeric antigen receptor therapy or other transgenic T cell therapy
- Known history of HIV, hepatitis B (HBsAg positive and HBV DNA detectable), or hepatitis C virus infection
- History of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases
- Any other factors deemed unsuitable by the researcher for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive the in vivo CAR-T drug based on LNP-mRNA as an investigational treatment for hematologic malignancies.
Multiple visits during treatment period for dosing and safety assessments
Duration - Up to 24 months
Participants are monitored for long-term safety and disease progression after treatment completion.
Regular visits for up to 2 years
Trial Site Locations
Total: 1 location
1
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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