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Clinical Trials in China / NCT07312630
Recruiting Phase EARLY_PHASE1

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

NCT07312630 · tracked via the Priya Life Science China tracker
Sponsor
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Phase
Phase EARLY_PHASE1
Started
2025-09-25
Last updated
2025-12-31

Condition(s) studied

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

Investigational drug(s) / intervention(s)

LV009 Injection Infusion

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
PersonGen.Anke Cellular Therapeutice Co., Ltd. Hefei Anhui Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07312630 on ClinicalTrials.gov ↗ ← All trials in China