Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies

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

This clinical trial is designed as a single-arm, open-label, single-center, investigator-initiated, early-phase study. Its primary objective is to evaluate the safety of LV009 Injection in subjects with relapsed/refractory CD19-positive hematolymphoid malignancies.

Study Overview

• Status: Recruiting
• Conditions: Acute Lymphoblastic Leukemia; Non-Hodgkin Lymphoma
• Intervention / Treatment: Biological: LV009 Injection

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yang Xu, MD; Phone Number: +86-13732628683; Email: xuyang1020@126.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Yang Xu, MD; Phone Number: +86-13732628683; Email: xuyang1020@126.com
      • Principal Investigator: Yang Xu, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18 to 70 years (inclusive), irrespective of sex and race.
2. Life expectancy greater than 12 weeks.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
4. Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
5. Adequate hepatic, renal, and cardiopulmonary function
6. Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL

Exclusion Criteria:

1. Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
2. History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
3. Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
4. Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
5. Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
6. Patients who have participated in other clinical studies within 1 month prior to screening.
7. Evidence of central nervous system involvement at the time of screening.

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: LV009 Injection	Biological: LV009 Injection; Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse Events Occurring During the Treatment Period (TEAEs), Serious Adverse Events (SAEs), Replication-Competent Lentivirus (RCL), and Lentiviral Insertion Site Status (Assessed according to the Common Terminology Criteria for Adverse Events, Version 5.0, NCI CTCAE v5.0)	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2027

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• 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-012-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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