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

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

Study Overview

• Status: Recruiting
• Conditions: Non-Hodgkin Lymphoma (NHL); Acute Lymphoblastic Leukemia (ALL), Adult
• Intervention / Treatment: Biological: LV009 Injection Infusion

Detailed Description

Within each dose group, the next subject may be dosed after the previous subject has completed at least 14 days of safety observation. Following the assessment of dose-limiting toxicity (DLT) within 28 days after the last subject in each dose group completed a single dose, and upon approval by the Safety Review Committee (SRC) based on clinical safety data to proceed to the next dose group, enrollment and treatment for the next dose group may commence. If one DLT occurs among the first three subjects in a dose group, three additional subjects must be added to that group (bringing the total to six subjects for DLT assessment): If no DLT occurs in the 3 additional subjects, dose escalation continues. If 1 DLT occurs in the 3 additional subjects, dose escalation is halted. If >1 DLT occurs in the 3 additional subjects, dose escalation is halted, and the dose must be reduced by one level to continue enrolling 3 subjects for DLT assessment.

• Study Type: Interventional
• Enrollment (Estimated): 19
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xingbing Wang, Doctor; Phone Number: +86-13856007984; Email: wangxingbing@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Recruiting
      • PersonGen.Anke Cellular Therapeutice Co., Ltd.
      • Contact: Huimin Meng PersonGen.Anke Cellular Therapeutice Co., Ltd., Doctor; Phone Number: +86-18015580390; Email: huimin.meng@persongen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions
• Expected survival time exceeds 12 weeks
• ECOG performance status 0-2
• Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
• Liver and kidney function, as well as cardiopulmonary function, meet requirements.
• Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL.
• Subjects must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection.
• Within 5 days prior to the study drug infusion, subjects must not receive therapeutic doses of corticosteroids (>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents.

Exclusion Criteria:

• Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.
• Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.
• Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).
• Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.)
• Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] class ≥ III), and severe arrhythmias.
• Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication.
• Patients with chronic progressive neurological diseases should be excluded.
• Patients who have not recovered from acute toxic effects following prior treatment must be excluded.
• Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for inclusion).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection of CD19-Targeted Chimeric Antigen Receptor T Cells; 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.	Biological: LV009 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAE	According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	From the start of infusion of the study drug to 3 months after drug infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Tmax)	Time to peak concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection	Within 28 days after the transfusion and within 90 days after the transfusion
(Cmax)	Maximum concentration of CD19 CAR-T expansion in peripheral blood following administration of LV009 injection	Within 28 days after the transfusion and within 90 days after the transfusion
AUC	Area under the curve of CD19 CAR-T expansion in peripheral blood 28 days after administration of LV009 injection	Within 28 days after administration of LV009 injection

Collaborators and Investigators

• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 12, 2027

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: CAR-T; CD19
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: PG-012-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because the patent rights have not yet been determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No