Actively Recruiting
An Exploratory Clinical Study of CAR-T Cell Immunotherapy Using Polymer-lipid Particles to Deliver CAR1920 mRNA Targeting CD19/CD20 for Thetreatment of Relapsed/Refractory B-cell Lymphoma/Leukemia
Led by Daihong Liu · Updated on 2026-01-07
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new CAR-T cell immunotherapy that uses polymer-lipid nanoparticles to deliver CD19/CD20 dual-targeting InViVoCAR1920 mRNA. This therapy is studied as a first-line consolidation treatment for patients with relapsed or refractory B-cell lymphoma or leukemia, aiming to improve tumor clearance and reduce recurrence by targeting two antigens simultaneously. The study is a phase 2 clinical trial sponsored by Daihong Liu. The trial involves a single treatment using polymer-lipid nanoparticles to deliver mRNA that instructs T cells to target CD19 and CD20 antigens on B-cell tumors. This method allows for in situ generation of CAR-T cells without the need for ex vivo manipulation, potentially shortening treatment time and avoiding T-cell exhaustion. Patients with relapsed or refractory B-cell malignancies who meet specific criteria will receive this experimental therapy. Participants will be monitored for safety and response at several time points including 3 months, 6 months, and 90 days after treatment. Assessments will include laboratory tests, imaging examinations, and evaluations of overall survival, progression-free survival, disease-free survival, and recurrence rates. Safety and maximum tolerated dose will be primary outcomes measured three months post-treatment. The total study period extends until August 2027, with regular follow-ups to track treatment effects and adverse events.
CONDITIONS
Brief Title
Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed/Refractory B-cell Lymphoma/Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent and willing to comply with study procedures
- Diagnosed with relapsed or refractory B-cell lymphoma/leukemia according to WHO 2016 criteria
- Specific B-cell tumors including B-ALL, indolent B-cell lymphomas, aggressive B-cell lymphomas meeting defined relapse or refractory criteria
- Age between 18 and 85 years inclusive
- ECOG performance status score of 0 to 2
- Expected survival longer than 14 days after consent
- Hemoglobin level at least 60 g/L (transfusions allowed)
- Absolute neutrophil count at least 1,000/μl and platelet count at least 45,000/μl (transfusions allowed)
- Adequate liver, kidney, heart, and lung function as specified
- Agreement to use contraception from enrollment until 6 months post-study if pregnancy plans exist
You will not qualify if you...
- Previous CAR or genetically modified T-cell therapy
- History of severe allergic reactions to certain antibiotics
- Active HIV infection, active hepatitis B virus infection, or uncontrolled systemic infection
- Significant liver or kidney impairment unrelated to blood cancer
- Recent serious heart conditions or procedures within 12 months
- Severe medical conditions affecting study participation or outcomes
- Pregnancy or breastfeeding
- Inability to comply with study visits or procedures
- Other active or recent malignant tumors except certain skin and in situ cancers
- Recent live vaccine within 6 weeks prior to conditioning
- Major surgery within 14 days or planned during treatment
- Severe physical or mental illnesses or lab abnormalities increasing risk or affecting results
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 6 months after treatment
Participants receive Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy to treat relapsed or refractory B-cell lymphoma/leukemia.
Visits scheduled as needed during treatment and monitoring period
Duration - Up to 6 months after treatment
Participants are monitored for safety, maximum tolerated dose, response rates, survival, and recurrence following treatment.
Approximately 3 to 6 follow-up visits
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
L
Li-Ping Dou, Dr.
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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