Actively Recruiting
Phase 2 Study of CAR-T Cell Therapy Using Polymer-Lipid Nanoparticles Delivering CD19CD20 Dual-Targeting CAR1920 mRNA for Treatment of Relapsed or Refractory B-cell Lymphoma and Leukemia
Led by Daihong Liu · Updated on 2026-01-07
10
Participants Needed
1
Research Sites
N/A
Total Duration
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 CD19CD20 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
Research Team
L
Li-Ping Dou, Dr.
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