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Recruiting Phase 2 NCT07321301

Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed/Refractory B-cell Lymphoma/Leukemia

Trial Parameters

Condition B-cell Lymphoma Refractory
Sponsor Daihong Liu
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 10
Sex ALL
Min Age 14 Years
Max Age 85 Years
Start Date 2025-09-01
Completion 2027-08-31
Interventions
Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy

Brief Summary

The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed/refractory B-cell lymphoma/leukemia.

Eligibility Criteria

Inclusion Criteria: 1. Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol; 2. Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options; 3. Must meet the following criteria for R/R B-cell malignant tumors: (1) B-cell tumors include 3 categories: * B-cell acute lymphoblastic leukemia (B-ALL); ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasm

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