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

NCT07284927 | Recruiting Phase 1

• 1 other identifier: PG-012-3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Hodgkin Lymphoma; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LV009 Injection

EXPERIMENTAL

Biological: LV009 Injection

Interventions

LV009 Injection BIOLOGICAL

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

LV009 Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study Contacts

Yang Xu, MD

CONTACT

+86-13732628683; xuyang1020@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)