RecruitingEarly Phase 1NCT07312630

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

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Enrollment

19 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

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 Criteria9

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).