RecruitingEarly Phase 1NCT07312630

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


Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Enrollment

19 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests LV009 injection — a CAR-T cell therapy that targets a protein called CD19 found on certain blood cancer cells — in people with relapsed or treatment-resistant non-Hodgkin lymphoma or acute lymphoblastic leukemia (a type of fast-growing blood cancer). **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed CD19-positive non-Hodgkin lymphoma or acute lymphoblastic leukemia that has come back or not responded to treatment - Your cancer meets criteria for relapsed/refractory disease per standard guidelines - Your blood counts, liver, kidney, and heart-lung function are adequate - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - Your cancer does not have the CD19 protein - Your blood counts or organ function are too low - You have had recent serious infections or other conditions preventing treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLV009 Injection Infusion

A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU.


Locations(1)

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China

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NCT07312630


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