Actively Recruiting

Early Phase 1
Age: 18Years - 70Years
All Genders
NCT07312630

Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies

Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-31

19

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.

CONDITIONS

Official Title

Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 70 years old (inclusive)
  • Expected survival time exceeds 12 weeks
  • ECOG performance status between 0 and 2
  • Diagnosed with relapsed or refractory CD19-positive hematologic malignancies, including non-Hodgkin lymphoma and acute lymphoblastic leukemia
  • Liver, kidney, and cardiopulmonary functions meet study requirements
  • Absolute lymphocyte count of at least 0.5 × 10^9/L
  • Platelet count of at least 50 × 10^9/L
  • CD3-positive T cell count of at least 150 cells/μL
  • Body temperature of 38°C or lower (excluding tumor fever) within 24 hours before study drug infusion
  • No significant active infection
  • No therapeutic doses of corticosteroids (>5 mg/day prednisone or equivalent) or other immunosuppressive agents within 5 days before study drug infusion
Not Eligible

You will not qualify if you...

  • Need for long-term immunosuppressive therapy during screening
  • Stroke or seizure within 6 months before informed consent
  • Malignant tumors other than the study disease (except carcinoma in situ)
  • Positive for Hepatitis B surface antigen, Hepatitis B core antibody with abnormal HBV DNA, Hepatitis C antibody with positive HCV RNA, HIV antibody, Cytomegalovirus DNA, or Syphilis
  • Severe cardiac conditions including unstable angina, recent myocardial infarction (within 6 months), heart failure NYHA class III or higher, or severe arrhythmias
  • Unstable systemic diseases such as severe liver, kidney, or metabolic disorders requiring medication
  • Chronic progressive neurological diseases
  • Not recovered from acute toxic effects of prior treatments
  • Active infections requiring systemic treatment or uncontrolled infections (mild urogenital or upper respiratory infections allowed)

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

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China, 230088

Actively Recruiting

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Research Team

X

Xingbing Wang, Doctor

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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