Actively Recruiting

Phase 2
Age: 14Years - 85Years
All Genders
NCT07321301

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

Led by Daihong Liu · Updated on 2026-01-07

10

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has voluntarily given informed consent and agrees to comply with study procedures
  • Diagnosed with relapsed or refractory B-cell lymphoma or leukemia per WHO 2016 criteria
  • Meets specific criteria for B-cell tumors including B-ALL, indolent and aggressive lymphomas
  • Aged between 18 and 85 years
  • ECOG performance status of 0 to 2
  • Expected survival longer than 14 days after consent
  • Hemoglobin level at least 60 g/L (transfusion allowed)
  • Absolute neutrophil count at least 1,000/µl and platelet count at least 45,000/µl (transfusion allowed)
  • Adequate liver, kidney, heart, and lung function as defined by laboratory and clinical measures
  • Agreement to use contraception from before enrollment until 6 months post-study
Not Eligible

You will not qualify if you...

  • Previous CAR or genetically modified T-cell therapy
  • History of severe allergic reactions to certain drugs
  • Active HIV infection, active hepatitis B infection or uncontrolled systemic infections
  • Significant liver or kidney impairment unrelated to lymphoma
  • Serious heart diseases or events within 12 months prior to enrollment
  • Other severe medical conditions affecting study participation
  • Pregnancy or breastfeeding
  • Unable or unwilling to comply with study visits and procedures
  • Other active or recent cancers except certain skin cancers or carcinoma in situ
  • Recent live vaccine within 6 weeks prior to treatment
  • Major surgery within 14 days before treatment or planned during study
  • Other severe physical, mental illnesses or lab abnormalities increasing study risk or interfering with results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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Research Team

L

Li-Ping Dou, Dr.

CONTACT

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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