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

NCT07312630 | Recruiting Early Phase 1

• 1 other identifier: PG-012-8
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Lymphoblastic Leukemia (ALL), Adult; Non-Hodgkin Lymphoma (NHL)

Keywords

CD19; CAR-T

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• (Tmax)

  Within 28 days after the transfusion and within 90 days after the transfusion

• (Cmax)

  Within 28 days after the transfusion and within 90 days after the transfusion

• AUC

  Within 28 days after administration of LV009 injection

Study Arms (1)

Injection of CD19-Targeted Chimeric Antigen Receptor T Cells

EXPERIMENTAL

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

Interventions

LV009 Injection Infusion BIOLOGICAL

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.

Injection of CD19-Targeted Chimeric Antigen Receptor T Cells

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, 230088, 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

Xingbing Wang, Doctor

CONTACT

+86-13856007984; wangxingbing@ustc.edu.cn

Study Design

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

Model Details: LV009 Injection

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 31, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)