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

NCT ID: NCT07312630

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2027-12-12

Brief Summary

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

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.

Conditions

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

Keywords

CD19; CAR-T

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LV009 Injection Infusion

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PersonGen.Anke Cellular Therapeutice Co., Ltd.

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingbing Wang, Doctor

Role: CONTACT

Phone: +86-13856007984

Email: wangxingbing@ustc.edu.cn

Facility Contacts

Huimin Meng PersonGen.Anke Cellular Therapeutice Co., Ltd., Doctor

Role: primary

Other Identifiers

PG-012-8

Identifier Type: -

Identifier Source: org_study_id